Study Of OX40 Agonist PF-04518600 Alone And In Combinatio... | NCT02315066 | Trialant
NCT02315066
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 21, 2022Actual
Enrollment
174Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
PF-04518600
PF-04518600
PF-04518600 plus PF-05082566
PF-04518600 plus PF-05082566
Countries
United States
France
Japan
Netherlands
Protocol Section
Identification Module
NCT ID
NCT02315066
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B0601002
Secondary IDs
ID
Type
Description
Link
2014-004107-75
EudraCT Number
B0601002
Other Identifier
Alias Study Number
OX40
Other Identifier
Alias Study Number
Brief Title
Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
Official Title
A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2022
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
Apr 23, 2015Actual
Primary Completion Date
Nov 12, 2020Actual
Completion Date
Nov 12, 2020Actual
First Submitted Date
Dec 4, 2014
First Submission Date that Met QC Criteria
Dec 9, 2014
First Posted Date
Dec 11, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 10, 2021
Results First Submitted that Met QC Criteria
Feb 18, 2022
Results First Posted Date
Apr 21, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 18, 2022
Last Update Posted Date
Apr 21, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Immunotherapy
PF-04518600
PF-05082566
solid tumors
tumors
neoplasm metastasis
Phase 1
hepatocellular carcinoma
HCC
liver cancer
ocular melanoma
melanoma
clear cell renal cell carcinoma
RCC
kidney cancer
head and neck squamous cell carcinoma
HNSCC
head and neck cancer
cervical cancer
cancer of the cervix
gastric cancer
stomach cancer
non small cell lung cancer
NSCLC
lung cancer
urothelial bladder carcinoma
bladder cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
174Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-04518600
Experimental
OX40 agonist
Drug: PF-04518600
PF-04518600 plus PF-05082566
Experimental
OX40 (CD134) agonist plus 4-1BB (CD137) agonist
Drug: PF-04518600 plus PF-05082566
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-04518600
Drug
Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1
DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting >7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.
The first 2 cycles of treatment (Day 1 up to Day 28)
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A
Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.
Number of Participants With Laboratory Test Abnormalities in Part A
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A
ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.
CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm.
PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm.
Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed.
Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.
Part B2
Arm 1 only:
Ocular melanoma patients with advanced/metastatic disease, or
Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. [Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.] Any questions on prior treatment may be discussed with the Sponsor.
Arm 2 only:
Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. [Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.]
Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function
Exclusion Criteria:
Brain metastases requiring steroids
Major surgery, Radiation therapy within 4 weeks of starting study treatment (except: palliative radiotherapy to a limited field is allowed after consultation with sponsor's medical monitor at any time during study participation, including during screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
Active and clinically significant bacterial, fungal, or viral infection
History of active autoimmune disorders
History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy
Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)
Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2)
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
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e005471. doi: 10.1136/jitc-2022-005471.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 174 participants were enrolled in this study, and 174 of them received study treatment. For Part A, 87 participants were enrolled and treated with PF-04518600 at several dose levels. For Part B, 87 participants were enrolled and treated with PF-04518600+utomilumab at several dose levels.
Recruitment Details
Part A (PF-04518600 monotherapy) included Part A1 and Part A2 Part B(PF-04518600 plus utomilumab [PF-05082566] combination therapy) included Part B1 and Part B2
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG001
Part A1: PF-04518600 0.1mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0.05
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 2, 2018
Nov 10, 2021
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
OX40
4-1BB
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Open-label
Who Masked
Not provided
PF-04518600
PF-04518600
Drug
Part A2 - patients with hepatocellular carcinoma will be randomized to receive treatment with PF-04518600 at various doses administered intravenously
PF-04518600
PF-04518600 plus PF-05082566
Drug
Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.
PF-04518600 plus PF-05082566
PF-04518600 plus PF-05082566
Drug
Part B2 - patients with select tumor types (ocular melanoma, cutaneous/acral melanoma or non-small cell lung cancer) will be treated at dose levels based on the OBD selected in Part 1.
PF-04518600 plus PF-05082566
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick [protein, blood], microscopy [urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells], miscellaneous [urine casts and bacteria]).
The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)
Number of Participants With DLTs in Part B1
DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting >7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.
The First 2 Cycles of Treatment (Day 1 up to Day 28)
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B
Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.
Number of Participants With Laboratory Test Abnormalities in Part B
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick [protein, blood], microscopy [urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells], miscellaneous [urine casts and bacteria]).
The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A
PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.
PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.
Baseline up to 24 months post first dose
Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A
TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.
Baseline up to 24 months post first dose
Number of Participants Having Stable Disease (SD) in Part A
SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A
DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.
CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 mm) and all target lesions must be assessed.
PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A
OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44.
Baseline up to 24 months post first dose.
Overall Survival Rates at Months 6, 12, and 24 in Part A
Probability of survival at 6, 12, and 24 months after the first dose of study treatment.
Baseline up to 24 months post first dose.
Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A
Cmax was defined as maximum observed serum concentration and can be observed directly from data.
Css,max was the Cmax on C3D1.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A
Cav was defined as average serum concentration over the dosing interval.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.
Vss was defined as volume of distribution at steady state.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
Baseline up to end of treatment (maximum of 14 weeks).
Mean Unbound Cell Surface OX40 in Part A1
Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses.
Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1
ORR Assessed by RECIST Version 1.1 and irRECIST in Part B
ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.
CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm.
PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm.
Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median PFS in Part B
PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.
PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median TTP in Part B
TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.
Baseline up to 24 months post first dose.
Number of Participants Having SD in Part B
SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median DoR in Part B
DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.
CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 mm) and all target lesions must be assessed.
PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.
Baseline up to 24 months post first dose.
Kaplan-Meier Estimate of Median OS in Part B
OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months.
Baseline up to 24 months post first dose.
Overall Survival Rates at Months 6, 12, and 24 in Part B
Probability of survival at 6, 12, and 24 months after the first dose of study treatment.
Baseline up to 24 months post first dose.
Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B
Cmax was defined as maximum observed serum concentration and can be observed directly from data.
Css,max was the Cmax on C3D1.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B
Cav was defined as average serum concentration over the dosing interval.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
CL of PF-04518600 Following Multiple Doses on C3D1 in Part B
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B
Vss was defined as volume of distribution at steady state.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B
Cmax was defined as maximum observed serum concentration and can be observed directly from data.
Css,max was the Cmax on C3D1.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Cav of Utomilumab Following Multiple Doses on C3D1 in Part B
Cav was defined as average serum concentration over the dosing interval.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
CL of Utomilumab Following Multiple Doses on C3D1 in Part B
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Vss of Utomilumab Following Multiple Doses on C3D1 in Part B
Vss was defined as volume of distribution at steady state.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Rac of Utomilumab Following Multiple Doses on C3D1 in Part B
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Number of Participants With ADA and NAb Against PF-04518600 in Part B
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
Baseline up to end of treatment (maximum of 14 weeks).
Number of Participants With ADA and NAb Against Utomilumab in Part B
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
Baseline up to end of treatment (maximum of 14 weeks).
Keck Hospital of USC
Los Angeles
California
90033
United States
LAC+USC Medical Center
Los Angeles
California
90033
United States
USC/Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
Ronald Regan Medical Center
Los Angeles
California
90095
United States
UCLA Hematology & Oncology Clinic
Los Angeles
California
90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach
California
92663
United States
Medical Imaging Center of Southern California, Inc.
Santa Monica
California
90403
United States
Santa Monica UCLA Hematology & Oncology Clinic
Santa Monica
California
90404
United States
UConn Health, Pharmacy
Farmington
Connecticut
06030-2205
United States
UConn Health, Neag Comprehensive Cancer Center
Farmington
Connecticut
06030
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
33612
United States
Massachusetts General Hospital (MGH)
Boston
Massachusetts
02114
United States
Brigham & Women's Hospital (BWH)
Boston
Massachusetts
02115
United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston
Massachusetts
02215
United States
Dana-Farber Cancer Institute (DFCI)
Boston
Massachusetts
02215
United States
Massachusetts General/Chelsea HealthCare Center
Chelsea
Massachusetts
02150
United States
Mass General/North Shore Center for Outpatient Care
Danvers
Massachusetts
01923
United States
Mass General West
Waltham
Massachusetts
02451
United States
Columbia University Medical Center - Herbert Irving Pavilion
New York
New York
10032
United States
Methodist Hospital-Pathology
Houston
Texas
77030
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
Groupe hospitalier Pitie Salpetriere
Paris
75013
France
Institut Gustave Roussy
Villejuif
94805
France
National Cancer Center Hospital East
Kashiwa
Chiba
277-8577
Japan
The Netherlands Cancer Institute
Amsterdam
1066 CX
Netherlands
Slotervaart Hospital/Antoni van Leeuwenhoek
Amsterdam
1066 EC
Netherlands
Erasmus MC
Rotterdam
3015 GD
Netherlands
Derived
Diab A, Hamid O, Thompson JA, Ros W, Eskens FALM, Doi T, Hu-Lieskovan S, Klempner SJ, Ganguly B, Fleener C, Wang X, Joh T, Liao K, Salek-Ardakani S, Taylor CT, Chou J, El-Khoueiry AB. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res. 2022 Jan 1;28(1):71-83. doi: 10.1158/1078-0432.CCR-21-0845. Epub 2021 Oct 6.
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
FG008
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
FG009
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
FG010
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
FG011
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
FG012
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
FG013
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
FG0002 subjects
FG00110 subjects
FG00211 subjects
FG00312 subjects
FG00413 subjects
FG0054 subjects
FG00616 subjects
FG00719 subjects
FG00811 subjects
FG00912 subjects
FG01012 subjects
FG01111 subjects
FG01211 subjects
FG01330 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0063 subjects
FG0075 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
NOT COMPLETED
FG0002 subjects
FG00110 subjects
FG0029 subjects
FG00311 subjects
FG00411 subjects
FG0053 subjects
FG00613 subjects
FG00714 subjects
FG00811 subjects
FG00911 subjects
FG01012 subjects
FG01111 subjects
FG01210 subjects
FG01330 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0112 subjects
FG0120 subjects
FG0134 subjects
Death
FG0002 subjects
FG0017 subjects
FG0026 subjects
FG00311 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject refused further follow-up
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Study ongoing at date of cut-off
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The baseline analysis population included all enrolled patients who received at least one full or partial IV infusion of study drug PF-04518600.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
BG008
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
BG009
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
BG010
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
BG011
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
BG012
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
BG013
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG00110
BG00211
BG00312
BG00413
BG0054
BG00616
BG00719
BG00811
BG00912
BG01012
BG01111
BG01211
BG01330
BG014174
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Less than 18 years old
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0013
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
WHITE
Title
Measurements
BG0001
BG00110
BG002
Body mass index
Mean
Standard Deviation
kilograms per meter squared (kg/m^2)
Title
Denominators
Categories
Title
Measurements
BG00027.5± 6.7
BG00126.6± 3.6
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
Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1
DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting >7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.
The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.
Posted
Count of Participants
Participants
The first 2 cycles of treatment (Day 1 up to Day 28)
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A
Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Analysis population included all enrolled participants who received at least one full or partial IV infusion of study drug PF-04518600.
Posted
Count of Participants
Participants
AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Primary
Number of Participants With Laboratory Test Abnormalities in Part A
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick [protein, blood], microscopy [urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells], miscellaneous [urine casts and bacteria]).
Analysis Population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Count of Participants
Participants
The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Primary
Number of Participants With DLTs in Part B1
DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting >7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.
The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.
Posted
Count of Participants
Participants
The First 2 Cycles of Treatment (Day 1 up to Day 28)
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Primary
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B
Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Count of Participants
Participants
AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Primary
Number of Participants With Laboratory Test Abnormalities in Part B
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick [protein, blood], microscopy [urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells], miscellaneous [urine casts and bacteria]).
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Count of Participants
Participants
The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A
ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.
CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm.
PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm.
Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Number
percentage of participants
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Secondary
Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A
PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.
PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Secondary
Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A
TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Secondary
Number of Participants Having Stable Disease (SD) in Part A
SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Count of Participants
Participants
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Secondary
Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A
DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.
CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 mm) and all target lesions must be assessed.
PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Secondary
Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A
OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Secondary
Overall Survival Rates at Months 6, 12, and 24 in Part A
Probability of survival at 6, 12, and 24 months after the first dose of study treatment.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
Posted
Number
95% Confidence Interval
Probability of survival
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Secondary
Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A
Cmax was defined as maximum observed serum concentration and can be observed directly from data.
Css,max was the Cmax on C3D1.
The pharmacokinetic (PK) parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram/milliliter (µg/mL)
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Secondary
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram•hour/milliliter (µg•hr/mL)
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Secondary
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Secondary
Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.
Posted
Mean
Standard Deviation
days
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Secondary
Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Secondary
Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A
Cav was defined as average serum concentration over the dosing interval.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Secondary
Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.
Posted
Geometric Mean
Geometric Coefficient of Variation
milliliter/hour/kilogram (mL/hr/kg)
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Secondary
Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.
Vss was defined as volume of distribution at steady state.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.
Posted
Geometric Mean
Geometric Coefficient of Variation
milliliter/kilograms (mL/kg)
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Secondary
Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Secondary
Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.
Posted
Count of Participants
Participants
Baseline up to end of treatment (maximum of 14 weeks).
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Secondary
Mean Unbound Cell Surface OX40 in Part A1
Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses.
Analysis Population included all enrolled participants with at least 1 of the OX40 evaluated at pre and/or post dose.
Posted
Mean
Standard Deviation
percentage of baseline concentration
Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1
ID
Title
Description
OG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Secondary
ORR Assessed by RECIST Version 1.1 and irRECIST in Part B
ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.
CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10 mm.
PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm.
Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Number
Percentage of participants
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Kaplan-Meier Estimate of Median PFS in Part B
PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.
PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Kaplan-Meier Estimate of Median TTP in Part B
TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Number of Participants Having SD in Part B
SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Count of Participants
Participants
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Kaplan-Meier Estimate of Median DoR in Part B
DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.
CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 mm) and all target lesions must be assessed.
PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Kaplan-Meier Estimate of Median OS in Part B
OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Median
95% Confidence Interval
months
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Overall Survival Rates at Months 6, 12, and 24 in Part B
Probability of survival at 6, 12, and 24 months after the first dose of study treatment.
Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
Posted
Number
95% Confidence Interval
Probability of survival
Baseline up to 24 months post first dose.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B
Cmax was defined as maximum observed serum concentration and can be observed directly from data.
Css,max was the Cmax on C3D1.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg.hr/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Secondary
t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.
Posted
Mean
Standard Deviation
days
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B
Cav was defined as average serum concentration over the dosing interval.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
CL of PF-04518600 Following Multiple Doses on C3D1 in Part B
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/hr/kg
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B
Vss was defined as volume of distribution at steady state.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/kg
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B
Cmax was defined as maximum observed serum concentration and can be observed directly from data.
Css,max was the Cmax on C3D1.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Secondary
t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.
Posted
Mean
Standard Deviation
days
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Cav of Utomilumab Following Multiple Doses on C3D1 in Part B
Cav was defined as average serum concentration over the dosing interval.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
CL of Utomilumab Following Multiple Doses on C3D1 in Part B
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/hr/kg
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Vss of Utomilumab Following Multiple Doses on C3D1 in Part B
Vss was defined as volume of distribution at steady state.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/kg
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Rac of Utomilumab Following Multiple Doses on C3D1 in Part B
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Secondary
Number of Participants With ADA and NAb Against PF-04518600 in Part B
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.
Posted
Count of Participants
Participants
Baseline up to end of treatment (maximum of 14 weeks).
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Secondary
Number of Participants With ADA and NAb Against Utomilumab in Part B
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.
Posted
Count of Participants
Participants
Baseline up to end of treatment (maximum of 14 weeks).
ID
Title
Description
OG000
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Time Frame
AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B).
Description
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A1: PF-04518600 0.01mg/kg
Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
2
2
0
2
2
2
EG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
7
10
4
10
10
10
EG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
6
11
1
11
11
11
EG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
11
12
3
12
12
12
EG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
10
13
6
13
13
13
EG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
3
4
2
4
4
4
EG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
9
16
7
16
16
16
EG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
9
19
6
19
19
19
EG008
Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
10
11
5
11
11
11
EG009
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
8
12
2
12
12
12
EG010
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
10
12
3
12
12
12
EG011
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
7
11
5
11
11
11
EG012
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
8
11
5
11
11
11
EG013
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
22
30
10
30
29
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG0030 affected12 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
Bradycardia
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Chest pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hernia pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Performance status decreased
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Syncope
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vascular purpura
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Disease progression
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Euthanasia
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Septic shock
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Seizure
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG0033 affected12 at risk
EG0043 affected13 at risk
EG0051 affected4 at risk
EG0063 affected16 at risk
EG0073 affected19 at risk
EG0080 affected11 at risk
EG0092 affected12 at risk
EG0104 affected12 at risk
EG0113 affected11 at risk
EG0126 affected11 at risk
EG0137 affected30 at risk
Lymph node pain
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Deposit eye
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Eye disorder
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Vision blurred
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Visual impairment
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0013 affected10 at risk
EG0021 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0024 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0022 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0014 affected10 at risk
EG0021 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0022 affected11 at risk
EG003
Asthenia
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Catheter site erythema
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Chills
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0012 affected10 at risk
EG0023 affected11 at risk
EG003
Face oedema
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Facial pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Fatigue
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0017 affected10 at risk
EG0026 affected11 at risk
EG003
Feeling cold
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Gait disturbance
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Influenza like illness
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Mass
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Oedema
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0020 affected11 at risk
EG003
Pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0013 affected10 at risk
EG0022 affected11 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cryptosporidiosis infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Localised infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Nail infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Skin infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Amylase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0022 affected11 at risk
EG003
Basophil count increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Blood glucose increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Blood sodium decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood uric acid increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cardiac murmur
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Electrocardiogram U-wave abnormality
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Eosinophil count increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
International normalised ratio increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Lipase increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Platelet count increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Transaminases increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Troponin increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Urobilinogen urine increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Weight decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Weight increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
White blood cell count increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0012 affected10 at risk
EG0024 affected11 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0013 affected10 at risk
EG0021 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0020 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0013 affected10 at risk
EG0021 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0022 affected11 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0024 affected11 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0022 affected11 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Prostatism
Reproductive system and breast disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected10 at risk
EG0021 affected11 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0022 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0013 affected10 at risk
EG0023 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0021 affected11 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Skin adhesion
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Embolism
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0021 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected10 at risk
EG0020 affected11 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Chest pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Eye pruritus
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Axillary pain
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Malaise
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Medical device site inflammation
General disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Stoma site discomfort
Injury, poisoning and procedural complications
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood glucose decreased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Blood potassium increased
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Device breakage
Product Issues
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bladder irritation
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Embolism venous
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Flushing
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Agitation
Psychiatric disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v21.0
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected10 at risk
EG0020 affected11 at risk
EG003
A decision was made by the sponsor to terminate further enrollment to the study on 03 Oct 2018 due to business reasons. The decision to terminate study enrollment was not based on any safety or regulatory concerns.
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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D002294
Carcinoma, Squamous Cell
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D000091662
Genital Diseases
D005770
Gastrointestinal Neoplasms
D005767
Gastrointestinal Diseases
D013272
Stomach Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D001745
Urinary Bladder Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C577122
utomilumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
10 subjects
FG0053 subjects
FG0069 subjects
FG0079 subjects
FG00810 subjects
FG0098 subjects
FG01010 subjects
FG0117 subjects
FG0128 subjects
FG01321 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0073 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0112 subjects
FG0122 subjects
FG0134 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
18 to 44 years old (18-44)
Title
Measurements
BG0000
BG0011
BG0022
BG0030
BG0040
BG0051
BG0060
BG0071
BG0082
BG0090
BG0101
BG0110
BG0120
BG0133
BG01411
45 to 64 years old (45-64)
Title
Measurements
BG0002
BG0017
BG0026
BG0032
BG0047
BG0051
BG0068
BG0079
BG0087
BG0097
BG0108
BG0114
BG0123
BG01314
BG01485
65 years old and more than 65 years old (>＝65)
Title
Measurements
BG0000
BG0012
BG0023
BG00310
BG0046
BG0052
BG0068
BG0079
BG0082
BG0095
BG0103
BG0117
BG0128
BG01313
BG01478
3
BG0031
BG0042
BG0050
BG0060
BG0073
BG0084
BG0094
BG0107
BG0113
BG0129
BG01310
BG01449
Male
BG0001
BG0018
BG0028
BG00311
BG00411
BG0054
BG00616
BG00716
BG0087
BG0098
BG0105
BG0118
BG0122
BG01320
BG014125
0
BG0031
BG0040
BG0051
BG0060
BG0072
BG0082
BG0094
BG0101
BG0110
BG0120
BG0132
BG01416
Not Hispanic or Latino
BG0002
BG0017
BG00211
BG00311
BG00413
BG0053
BG0068
BG00714
BG0089
BG0098
BG01011
BG01111
BG01211
BG01324
BG014143
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0068
BG0073
BG0080
BG0090
BG0100
BG0110
BG0120
BG0134
BG01415
9
BG0039
BG0048
BG0054
BG0066
BG0078
BG00810
BG0096
BG01010
BG0118
BG0128
BG01320
BG014117
BLACK
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0073
BG0080
BG0090
BG0100
BG0110
BG0120
BG0131
BG0146
ASIAN
Title
Measurements
BG0000
BG0010
BG0021
BG0033
BG0044
BG0050
BG0062
BG0075
BG0081
BG0092
BG0102
BG0113
BG0123
BG0134
BG01430
OTHER
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0094
BG0100
BG0110
BG0120
BG0133
BG01410
UNSPECIFIED
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0067
BG0072
BG0080
BG0090
BG0100
BG0110
BG0120
BG0132
BG01411
26.4
± 4.9
BG00328.9± 5.7
BG00425.9± 4.5
BG00522.8± 1.9
BG00626.2± 3.7
BG00725.5± 6.0
BG00825.3± 5.2
BG00926.7± 7.6
BG01025.5± 7.4
BG01125.0± 5.2
BG01223.5± 5.9
BG01325.2± 5.3
BG01425.2± 5.9
12
OG00413
OG0054
0
OG0040
OG0050
OG001
Part A1: PF-04518600 0.1mg/kg
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Number of Participants with all-causality TEAEs
Title
Measurements
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Number of Participants with treatment-related TEAEs
Title
Measurements
OG0002
OG0017
OG0027
OG003
Number of Participants with treatment-related SAEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Number of Participants with all-causality SAEs
Title
Measurements
OG0000
OG0014
OG0021
OG003
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00412
OG0054
OG00616
OG00719
Title
Denominators
Categories
Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0012
OG0024
OG003
Hematocrit (%) < 0.8 x LLN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
Platelets (10**3/mm**3) < 0.5 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN)
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
White Blood Cell Count (10**3/mm**3) < 0.6 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
White Blood Cell Count (10**3/mm**3) > 1.5 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG003
Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00312
Lymphocytes (%) < 0.8 x LLN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
Lymphocytes (%) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
Neutrophils (%) <0.8x LLN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Neutrophils (%) >1.2x ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PTT (sec) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00311
Basophils (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
Basophils (%) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
Eosinophils (%) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
Monocytes (%) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
Prothrombin (PT) (sec) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
PT International Ratio (INR) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Total Bilirubin (mg/dL) > 1.5 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Direct Bilirubin (mg/dL) > 1.5 x ULN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Indirect Bilirubin (mg/dL) > 1.5 x ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG003
Gamma GT (IU/L) > 3.0 x ULN
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
Alkaline Phosphatase (IU/L) > 3.0 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Albumin (g/dL) < 0.8 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Albumin (g/dL) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Creatinine (mg/dL) > 1.3 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Uric Acid (mg/dL) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Sodium (milliequivalent (mEq/L) < 0.95 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Sodium (mEq/L) > 1.05 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Potassium (mEq/L) < 0.9 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Potassium (mEq/L) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Chloride (mEq/L) < 0.9 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Chloride (mEq/L) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Calcium (mg/dL) < 0.9 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Calcium (mg/dL) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Magnesium (mg/dL) < 0.9 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Magnesium (mg/dL) > 1.1 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Phosphate (mg/dL) < 0.8 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Phosphate (mg/dL) > 1.2 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
T4 (free) (ng/dL) < 0.8 x LLN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0034
T4 (free) (ng/dL) > 1.2 x ULN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0034
TSH (UIU/mL) < 0.8 x LLN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
TSH (UIU/mL) > 1.2 x ULN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
Glucose (mg/dL) < 0.6 x LLN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Glucose (mg/dL) > 1.5 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Creatine Kinase (CK) (U/L) > 2.0 x ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Amylase (U/L) > 1.5 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Lipase (U/L) > 1.5 x ULN
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Urine Protein (Qual) >= 1
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Urine Blood/ hemoglobin(Hgb) (Qual) >= 1
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Urine RBC (/high power field (HPF)) >= 20
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Urine WBC (/HPF) >= 20
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Urine Epithelial Cells (/HPF) >= 6
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG00310
Urine Casts (/low power field(LPF) > 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0034
Urine Granular Casts (/LPF) > 1
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0034
Urine Hyaline Casts (/LPF) >1
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0037
Urine Bacteria (/HPF) > 20
ParticipantsOG0001
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00311
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Number of Participants with all-causality TEAEs
Title
Measurements
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Number of Participants with treatment-related TEAEs
Title
Measurements
OG0004
OG0016
OG0027
OG003
Number of Participants with treatment-related SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Number of Participants with all-causality SAEs
Title
Measurements
OG0005
OG0012
OG0023
OG003
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00010
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0004
OG0013
OG0024
OG003
Hematocrit (%) < 0.8 x LLN
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
Platelets (10**3/mm**3) < 0.5 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN)
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
White Blood Cell Count (10**3/mm**3) < 0.6 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
White Blood Cell Count (10**3/mm**3) > 1.5 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00310
Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00310
Lymphocytes (%) < 0.8 x LLN
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
Lymphocytes (%) > 1.2 x ULN
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Neutrophils (%) <0.8x LLN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Neutrophils (%) >1.2x ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Basophils (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00310
Basophils (%) > 1.2 x ULN
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00310
Eosinophils (%) > 1.2 x ULN
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00310
Monocytes (%) > 1.2 x ULN
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
PTT (sec) > 1.1 x ULN
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00311
Prothrombin (PT) (sec) > 1.1 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
PT International Ratio (INR) > 1.1 x ULN
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG0039
Total Bilirubin (mg/dL) > 1.5 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Direct Bilirubin (mg/dL) > 1.5 x ULN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Indirect Bilirubin (mg/dL) > 1.5 x ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Gamma GT (IU/L) > 3.0 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Alkaline Phosphatase (IU/L) > 3.0 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Albumin (g/dL) < 0.8 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Albumin (g/dL) > 1.2 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Creatinine (mg/dL) > 1.3 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Uric Acid (mg/dL) > 1.2 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Sodium (mEq/L) < 0.95 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Sodium (mEq/L) > 1.05 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Potassium (mEq/L) < 0.9 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Potassium (mEq/L) > 1.1 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Chloride (mEq/L) < 0.9 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Chloride (mEq/L) > 1.1 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Calcium (mg/dL) < 0.9 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Calcium (mg/dL) > 1.1 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Magnesium (mg/dL) < 0.9 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Magnesium (mg/dL) > 1.1 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Phosphate (mg/dL) < 0.8 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Phosphate (mg/dL) > 1.2 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
T4 (free) (ng/dL) < 0.8 x LLN
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
T4 (free) (ng/dL) > 1.2 x ULN
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
TSH (UIU/mL) < 0.8 x LLN
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG00310
TSH (UIU/mL) > 1.2 x ULN
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG00310
Glucose (mg/dL) < 0.6 x LLN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Glucose (mg/dL) > 1.5 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Creatine Kinase (CK) (U/L) > 2.0 x ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Amylase (U/L) > 1.5 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Lipase (U/L) > 1.5 x ULN
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Urine Protein (Qual) >= 1
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Urine Blood/Hgb (Qual) >= 1
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Urine RBC (/HPF) >= 20
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
Urine WBC (/HPF) >= 20
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
Urine Epithelial Cells (/HPF) >= 6
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0037
Urine Casts (/LPF) > 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Urine Granular Casts (/LPF) > 1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Urine Hyaline Casts (/LPF) >1
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0035
Urine Bacteria (/HPF) > 20
ParticipantsOG0007
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
ORR per RECIST v1.1
Title
Measurements
OG0000
OG00110
OG0029.1
OG0030
OG0040
OG00525
OG0060
OG0070
ORR per irRECIST
Title
Measurements
OG0000
OG00110
OG0029.1
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Title
Measurements
OG0001.3(1.3 to 1.4)
OG0013.5(1.3 to 4.2)
OG0025.4(1.3 to 24.0)
OG0031.4(1.3 to 8.3)
OG0042.7(1.3 to 5.6)
OG0054.8(0.7 to NA)The upper limit was not estimable. Because the upper limit for PFS based on Kaplan-Meier method was not reached.
OG0063.0(1.5 to 3.7)
OG0072.8(1.7 to 3.6)
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Title
Measurements
OG0001.3(1.3 to 1.4)
OG0014.1(1.3 to 6.5)
OG0025.4(1.3 to 24.0)
OG0031.4(1.3 to 8.3)
OG0043.2(1.2 to 5.6)
OG0058.3(1.2 to NA)The upper limit was not estimable. Because the upper limit for TTP based on Kaplan-Meier method was not reached.
OG0063.2(1.5 to 3.7)
OG0072.8(1.7 to 3.6)
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Title
Measurements
OG0000
OG0015
OG0026
OG0036
OG0048
OG0051
OG0069
OG00710
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG0012.4(NA to NA)Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.
OG00221.4(NA to NA)Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.
OG003NA(NA to NA)Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG004NA(NA to NA)Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG005NA(NA to NA)Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG006NA(NA to NA)Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG007NA(NA to NA)Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Title
Measurements
OG00011(7.3 to 14.8)
OG00113.0(3.3 to 20.7)
OG00217.6(4.1 to NA)The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.
OG0039.0(3.8 to 17.2)
OG0047.4(5.1 to 19.1)
OG0057.5(0.7 to NA)The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.
OG00615.6(4.2 to NA)The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.
OG00723.9(6.5 to NA)The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
Survival Probability at Month 6
Title
Measurements
OG000100(100 to 100)
OG00168.6(30.5 to 88.7)
OG00288.9(43.3 to 98.4)
OG00375.0(40.8 to 91.2)
OG00467.7(34.9 to 86.5)
OG00550.0(5.8 to 84.5)
OG00662.5(31.7 to 82.5)
OG00783.9(57.9 to 94.5)
Survival Probability at Month 12
Title
Measurements
OG00050.0(0.6 to 91.0)
OG00151.4(14.3 to 79.6)
OG00255.6(20.4 to 80.5)
OG003
Survival Probability at Month 24
Title
Measurements
OG000NA(NA to NA)Number and ranges for 95% CI were not estimable due to both participants in the group have been censored or died before month 24.
OG001NA(NA to NA)Number and ranges for 95% CI were not estimable due to all participants in the group have been censored or died before month 24.
OG00244.4(13.6 to 71.9)
OG003
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0001
OG00110
OG00210
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000.231± NAGeometric CV was not calculated for n\<3.
OG0012.871± 24
OG0028.448± 17
OG003
CYCLE3/DAY1
ParticipantsOG0000
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00312
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0001
OG00110
OG00210
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG0053
ParticipantsOG00616
ParticipantsOG00717
Title
Measurements
OG0007.59± NAGeometric CV was not calculated for n\<3.
OG001303.5± 35
OG0021350± 20
OG003
CYCLE3/DAY1
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0001
OG00110
OG00210
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG001293.7± 34
OG002NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1590,1010.
OG00423000± NAGeometric CV was not calculated for n\<3.
OG006
CYCLE3/DAY1
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0001
OG00110
OG00210
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG0013.410± 1.0992
OG002NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 5.77,4.83.
OG00413.1± NAGeometric CV was not calculated for n\<3.
OG006
CYCLE3/DAY1
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0000
OG00110
OG0029
OG00312
OG0049
OG0053
OG00615
OG00716
Title
Denominators
Categories
Title
Measurements
OG0010.05952± 51749
OG0022.882± 61
OG00317.79± 32
OG00436.14± 48
OG005130± 41
OG0062.968± 55
OG00737.62± 47
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0000
OG0018
OG0027
OG0037
OG0048
OG0053
OG00614
OG00715
Title
Denominators
Categories
Title
Measurements
OG0010.8897± 151
OG0026.166± 36
OG00334.55± 18
OG00476.13± 20
OG005246.1± 32
OG0066.659± 37
OG00775.55± 29
OG002
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0000
OG0018
OG0027
OG0037
OG0048
OG0053
OG00614
OG00715
Title
Denominators
Categories
Title
Measurements
OG0010.3342± 151
OG0020.1448± 48
OG0030.1291± 18
OG0040.1171± 21
OG0050.1209± 32
OG0060.1739± 28
OG0070.1423± 31
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0000
OG0015
OG0020
OG0030
OG0041
OG0050
OG0061
OG0071
Title
Denominators
Categories
Title
Measurements
OG00139.17± 19
OG00455.3± NAGeometric CV was not calculated for n\<3.
OG00679.2± NAGeometric CV was not calculated for n\<3.
OG00794.3± NAGeometric CV was not calculated for n\<3.
Part A1: PF-04518600 0.3mg/kg
Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0000
OG0018
OG0026
OG0037
OG0048
OG0053
OG00614
OG00715
Title
Denominators
Categories
Title
Measurements
OG0010.9893± 110
OG0021.543± 32
OG0031.785± 12
OG0041.947± 12
OG0052.161± 13
OG0061.628± 19
OG0071.709± 21
OG003
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG006
Part A2: PF-04518600 30mg
Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG007
Part A2: PF-04518600 250mg
Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG00110
OG00211
OG00312
OG00413
OG0054
OG00616
OG00719
Title
Denominators
Categories
ADA ever-positive
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG0053
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0002
OG0019
OG0025
OG003
NAb ever-positive
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Part A1: PF-04518600 1.5mg/kg
Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG004
Part A1: PF-04518600 3.0mg/kg
Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
OG005
Part A1: PF-04518600 10mg/kg
Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.
Units
Counts
Participants
OG0002
OG0018
OG00210
OG0039
OG0048
OG0054
Title
Denominators
Categories
Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00054.65± 15.203
OG00151.54± 15.670
OG00244.85± 9.407
OG003
Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H))
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Free, CD4+ Central Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Free, CD4+ Effector Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Free, CD8+ Central Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Free, CD8+ Effector Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG003
Total, CD127lo Regulatory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Total, CD4+ Central Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Total, CD4+ Effector Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Total, CD8+ Central Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Total, CD8+ Effector Memory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose)
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG003
Total, FOXP3+ Regulatory T Cells (%) End of treatment
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
OG001
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
ORR per RECIST v1.1
Title
Measurements
OG0000
OG0018.3
OG0028.3
OG0030
OG0040
OG0053.3
ORR per irRECIST
Title
Measurements
OG0000
OG0018.3
OG0028.3
OG003
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.6 to 2.7)
OG0012.8(0.9 to 4.2)
OG0022.3(1.4 to 5.5)
OG0031.4(1.2 to 2.7)
OG0041.4(1.0 to 2.8)
OG0053.2(1.7 to 3.7)
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.6 to 2.7)
OG0012.8(0.9 to 4.2)
OG0022.6(1.4 to 5.5)
OG0031.4(0.9 to 2.7)
OG0041.4(1.0 to 2.8)
OG0053.3(1.7 to 4.3)
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0024
OG0034
OG0043
OG00514
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG001NA(NA to NA)Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG0022.8(NA to NA)Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.
OG003NA(NA to NA)Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG004NA(NA to NA)Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG005NA(NA to NA)Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Title
Measurements
OG0008.7(2.4 to 14.3)
OG0019.5(3.9 to 22.1)
OG00212.0(3.6 to 22.1)
OG00311.4(1.3 to 21.1)
OG0045.4(1.2 to 11.4)
OG00512.0(4.7 to 16.6)
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
Survival Probability at Month 6
Title
Measurements
OG00061.4(26.6 to 83.5)
OG00161.4(26.6 to 83.5)
OG00272.7(37.1 to 90.3)
OG00358.4(22.7 to 82.3)
OG00445.0(13.9 to 72.4)
OG00563.9(43.2 to 78.8)
Survival Probability at Month 12
Title
Measurements
OG00030.7(7.3 to 58.6)
OG00136.8(9.3 to 65.7)
OG00251.9(19.8 to 76.7)
OG003
Survival Probability at Month 24
Title
Measurements
OG00010.2(0.6 to 36.4)
OG00112.3(0.7 to 41.4)
OG00220.8(3.2 to 48.7)
OG003
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00010
OG00112
OG00211
OG00310
OG0049
OG00528
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
ParticipantsOG0049
ParticipantsOG00528
Title
Measurements
OG0002.290± 19
OG0016.965± 23
OG0027.644± 23
OG003
CYCLE3/DAY1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0038
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00010
OG00112
OG00211
OG00310
OG0049
OG00528
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0009
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
ParticipantsOG0047
ParticipantsOG00526
Title
Measurements
OG000270.7± 27
OG0011022± 29
OG0021177± 23
OG003
CYCLE3/DAY1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0035
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00010
OG00112
OG00211
OG00310
OG0049
OG00528
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0056
Title
Measurements
OG000283.5± 31
OG001NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1380,992.
OG002NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1800,1700.
OG004
CYCLE3/DAY1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00010
OG00112
OG00211
OG00310
OG0049
OG00528
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0056
Title
Measurements
OG0004.104± 1.2263
OG001NA± NAMean and Standard Deviation was not calculated for n\<3. And the individual values were 5.58,5.85.
OG002NA± NAMean and Standard Deviation was not calculated for n\<3. And the individual values were 6.98,6.1.
OG004
CYCLE3/DAY1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0009
OG00110
OG00210
OG0038
OG0047
OG00526
Title
Denominators
Categories
Title
Measurements
OG0000.2591± 148
OG0012.266± 39
OG0021.074± 21520
OG0035.327± 101
OG00430.59± 38
OG0052.671± 155
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0035
OG0045
OG00522
Title
Denominators
Categories
Title
Measurements
OG0001.013± 73
OG0015.175± 26
OG0026.664± 18
OG00312± 35
OG00457.15± 48
OG0056.815± 45
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0035
OG0045
OG00522
Title
Denominators
Categories
Title
Measurements
OG0000.2944± 73
OG0010.1725± 26
OG0020.1339± 18
OG0030.2481± 35
OG0040.1566± 48
OG0050.1861± 47
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0002
OG0010
OG0020
OG0031
OG0040
OG0051
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 42.6,46.1.
OG00367.4± NAGeometric CV was not calculated for n\<3.
OG00554.3± NAGeometric CV was not calculated for n\<3.
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0035
OG0045
OG00522
Title
Denominators
Categories
Title
Measurements
OG0001.374± 31
OG0011.593± 26
OG0021.762± 12
OG0031.361± 37
OG0041.861± 31
OG0051.413± 31
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00410
OG00527
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
ParticipantsOG00410
ParticipantsOG00527
Title
Measurements
OG0004.018± 33
OG0014.06± 39
OG00220.33± 43
OG003
CYCLE3/DAY1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00211
ParticipantsOG0039
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00410
OG00527
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG0039
ParticipantsOG0047
ParticipantsOG00526
Title
Measurements
OG000789.4± 23
OG001596± 43
OG0022465± 33
OG003
CYCLE3/DAY1
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0035
Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00410
OG00527
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0055
Title
Measurements
OG0001011± 20
OG001831± NAGeometric CV was not calculated for n\<3.
OG0022801± 25
OG003
CYCLE3/DAY1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00410
OG00527
Title
Denominators
Categories
CYCLE1/DAY1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0055
Title
Measurements
OG00011.37± 0.58595
OG0015.44± NAStandard Deviation was not calculated for n\<3.
OG0027.769± 2.2299
OG003
CYCLE3/DAY1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0009
OG0018
OG00211
OG0039
OG0047
OG00526
Title
Denominators
Categories
Title
Measurements
OG0000.03294± 1302300
OG0010.002776± 3859511
OG0020.08612± 1346874
OG0030.0413± 2825205
OG0040.3123± 56629
OG0050.0007531± 117304
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0002
OG0014
OG0026
OG0035
OG0044
OG00521
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1.36,0.691.
OG0010.5119± 225
OG0024.119± 77
OG0031.004± 1189
OG0043.903± 31
OG0050.3453± 1524
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0002
OG0014
OG0026
OG0035
OG0044
OG00521
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 0.0218,0.04.
OG0010.05817± 225
OG0020.03615± 77
OG0030.1483± 1187
OG0040.03813± 31
OG0050.08619± 1525
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0031
OG0042
OG0052
Title
Denominators
Categories
Title
Measurements
OG0006.7± NAGeometric CV was not calculated for n\<3.
OG0034.22± NAGeometric CV was not calculated for n\<3.
OG004NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 13.4,4.18.
OG005NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 6.46,5.02.
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG0002
OG0014
OG0026
OG0035
OG0044
OG00521
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1.23,0.493.
OG0010.5441± 120
OG0021.091± 69
OG0030.2673± 1381
OG0040.9041± 26
OG0050.391± 886
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00311
OG00411
OG00530
Title
Denominators
Categories
ADA ever-positive
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00528
Title
Measurements
OG0006
OG0015
OG0023
OG003
NAb ever-positive
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
OG002
Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG003
Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG004
Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg
Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
OG005
Part B2: PF-04518600 30mg + PF-05082566 20mg
Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.
Units
Counts
Participants
OG00010
OG00112
OG00212
OG0039
OG0049
OG00528
Title
Denominators
Categories
ADA ever-positive
Title
Measurements
OG0005
OG0019
OG0029
OG0035
OG0044
OG00522
NAb ever-positive
Title
Measurements
OG0004
OG0016
OG0027
OG003
1 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
1 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0071 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0071 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected16 at risk
EG0071 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0071 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0071 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0131 affected30 at risk
1 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0071 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
1 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
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EG0080 affected11 at risk
EG0091 affected12 at risk
EG0102 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
1 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0092 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0133 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0101 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0133 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0081 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0111 affected11 at risk
EG0120 affected11 at risk
EG0131 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0091 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0120 affected11 at risk
EG0130 affected30 at risk
0 affected
12 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected16 at risk
EG0070 affected19 at risk
EG0080 affected11 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
EG0121 affected11 at risk
EG0130 affected30 at risk
7
OG0047
OG0051
OG00611
OG00712
0
OG0040
OG0050
OG0061
OG0071
3
OG0046
OG0052
OG0067
OG0076
6
OG0044
OG0052
OG00610
OG0074
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0022
OG0034
OG0045
OG0053
OG0068
OG0075
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0072
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0052
OG0061
OG0070
12
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG00610
ParticipantsOG00717
Title
Measurements
OG0001
OG0012
OG0022
OG0035
OG0044
OG0054
OG0066
OG0078
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG00610
ParticipantsOG00717
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0061
OG0071
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0002
OG0017
OG0025
OG0037
OG0049
OG0054
OG0069
OG00710
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0061
OG0070
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00615
ParticipantsOG00718
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
OG0073
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00615
ParticipantsOG00718
Title
Measurements
OG0000
OG0011
OG0021
OG0032
OG0046
OG0053
OG0061
OG0075
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00615
ParticipantsOG00719
Title
Measurements
OG0060
OG0070
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00615
ParticipantsOG00719
Title
Measurements
OG0061
OG0073
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0002
OG0012
OG0024
OG0034
OG0043
OG0051
OG0063
OG0074
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG0069
ParticipantsOG00717
Title
Measurements
OG0001
OG0010
OG0022
OG0030
OG0040
OG0051
OG0061
OG0070
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0012
OG0023
OG0031
OG0042
OG0051
OG0062
OG0074
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG0069
ParticipantsOG00717
Title
Measurements
OG0001
OG0010
OG0023
OG0031
OG0043
OG0050
OG0062
OG0072
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0013
OG0027
OG0034
OG0043
OG0051
OG0064
OG0076
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG0069
ParticipantsOG00717
Title
Measurements
OG0000
OG0012
OG0023
OG0034
OG0042
OG0053
OG0060
OG0073
ParticipantsOG00410
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0014
OG0023
OG00310
OG0048
OG0051
OG0065
OG00712
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0022
OG0035
OG0042
OG0052
OG0064
OG0076
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0022
OG0035
OG0041
OG0050
OG0065
OG0076
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0013
OG0020
OG0031
OG0042
OG0050
OG0065
OG0075
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG0001
OG0020
OG0031
OG0041
OG0050
OG0063
OG0074
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0074
Title
Measurements
OG0030
OG0050
OG0060
OG0071
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0014
OG0020
OG0033
OG0043
OG0050
OG0066
OG0079
12
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0042
OG0050
OG0064
OG0075
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0011
OG0020
OG0034
OG0044
OG0050
OG00610
OG00710
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0013
OG0020
OG0034
OG0043
OG0050
OG0065
OG0077
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0021
OG0034
OG0042
OG0052
OG0061
OG0074
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0012
OG0022
OG0033
OG0044
OG0050
OG0062
OG0071
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0022
OG0031
OG0043
OG0050
OG0061
OG0072
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0013
OG0022
OG0032
OG0043
OG0051
OG0062
OG0074
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0062
OG0072
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0043
OG0050
OG0061
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0062
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0071
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0011
OG0020
OG0033
OG0042
OG0051
OG0060
OG0071
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0052
OG0063
OG0073
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0071
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG00714
Title
Measurements
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG00714
Title
Measurements
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0072
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG00615
ParticipantsOG00719
Title
Measurements
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0071
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG00615
ParticipantsOG00719
Title
Measurements
OG0010
OG0020
OG0031
OG0042
OG0052
OG0063
OG0076
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0016
OG0022
OG0035
OG0044
OG0051
OG0069
OG0075
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0074
Title
Measurements
OG0020
OG0030
OG0060
OG0070
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0075
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0042
OG0050
OG0064
OG0073
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0001
OG0015
OG0024
OG0034
OG0041
OG0051
OG0065
OG0075
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0011
OG0022
OG0033
OG0043
OG0052
OG0061
OG0072
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0053
OG0060
OG0072
ParticipantsOG00412
ParticipantsOG0054
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0010
OG0020
OG0033
OG0042
OG0052
OG0060
OG0070
ParticipantsOG00411
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG00713
Title
Measurements
OG0000
OG0013
OG0023
OG0031
OG0043
OG0052
OG0061
OG0073
ParticipantsOG0045
ParticipantsOG0051
ParticipantsOG0066
ParticipantsOG0074
Title
Measurements
OG0001
OG0011
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
ParticipantsOG0045
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0070
ParticipantsOG0048
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0076
Title
Measurements
OG0001
OG0014
OG0022
OG0035
OG0045
OG0050
OG0061
OG0074
ParticipantsOG00411
ParticipantsOG0052
ParticipantsOG0067
ParticipantsOG00716
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
5
OG0047
OG00522
1
OG0040
OG0050
5
OG0045
OG00510
7
OG0046
OG0059
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0004
OG0012
OG0023
OG0036
OG0044
OG0054
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0021
OG0033
OG0040
OG0051
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0011
OG0024
OG0032
OG0043
OG0056
ParticipantsOG00411
ParticipantsOG00528
Title
Measurements
OG0005
OG0015
OG0028
OG0036
OG0046
OG00510
ParticipantsOG00411
ParticipantsOG00528
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0051
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0008
OG0018
OG0029
OG0039
OG0049
OG00520
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0050
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0003
OG0015
OG0025
OG0037
OG0045
OG00515
ParticipantsOG0040
ParticipantsOG00529
Title
Measurements
OG0052
ParticipantsOG0040
ParticipantsOG00529
Title
Measurements
OG0056
ParticipantsOG00411
ParticipantsOG00528
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0053
ParticipantsOG00411
ParticipantsOG00528
Title
Measurements
OG0001
OG0013
OG0026
OG0034
OG0043
OG00512
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0001
OG0013
OG0026
OG0033
OG0044
OG00514
ParticipantsOG00411
ParticipantsOG00528
Title
Measurements
OG0001
OG0014
OG0025
OG0036
OG0045
OG0059
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0003
OG0013
OG0023
OG0036
OG0043
OG0059
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0003
OG0011
OG0023
OG0034
OG0042
OG0057
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0013
OG0022
OG0033
OG0043
OG00511
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0002
OG0011
OG0020
OG0030
OG0041
OG0053
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
ParticipantsOG0041
ParticipantsOG0052
Title
Measurements
OG0010
OG0021
OG0030
OG0040
OG0050
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG0020
OG0040
OG0050
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG0051
11
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0053
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0010
OG0022
OG0032
OG0042
OG0055
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0041
OG0051
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0010
OG0022
OG0033
OG0043
OG0053
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0012
OG0022
OG0031
OG0041
OG0055
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0011
OG0023
OG0030
OG0041
OG0052
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0042
OG0051
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0043
OG0052
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0041
OG0051
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0055
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0051
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0041
OG0051
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0041
OG0050
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0011
OG0024
OG0032
OG0041
OG0053
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0041
OG0052
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0046
ParticipantsOG00513
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
ParticipantsOG0046
ParticipantsOG00513
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0000
OG0012
OG0020
OG0030
OG0041
OG0054
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0002
OG0013
OG0024
OG0034
OG0043
OG0055
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0000
OG0013
OG0023
OG0032
OG0041
OG00510
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG0030
OG0050
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0002
OG0011
OG0022
OG0030
OG0040
OG0053
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0001
OG0013
OG0022
OG0030
OG0040
OG0057
ParticipantsOG00411
ParticipantsOG00530
Title
Measurements
OG0002
OG0015
OG0024
OG0032
OG0044
OG0057
ParticipantsOG00410
ParticipantsOG00528
Title
Measurements
OG0002
OG0015
OG0024
OG0031
OG0043
OG0057
ParticipantsOG00411
ParticipantsOG00522
Title
Measurements
OG0001
OG0013
OG0021
OG0032
OG0042
OG0054
ParticipantsOG00411
ParticipantsOG00529
Title
Measurements
OG0002
OG0014
OG0024
OG0033
OG0042
OG0057
ParticipantsOG0046
ParticipantsOG00512
Title
Measurements
OG0005
OG0015
OG0022
OG0032
OG0042
OG0056
ParticipantsOG0043
ParticipantsOG00512
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
ParticipantsOG0041
ParticipantsOG0059
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
ParticipantsOG0045
ParticipantsOG00511
Title
Measurements
OG0001
OG0012
OG0022
OG0030
OG0044
OG0055
ParticipantsOG00410
ParticipantsOG00518
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
0
OG0040
OG00525
OG0060
OG0070
41.7
(15.2 to 66.5)
OG00433.8(10.5 to 59.4)
OG00550.0(5.8 to 84.5)
OG00654.7(25.4 to 76.6)
OG00758.4(31.6 to 77.8)
NA
(NA to NA)
Number and ranges for 95% CI were not estimable due to all participants in the group have been censored or died before month 24.
OG00416.9(2.7 to 41.7)
OG00525.0(0.9 to 66.5)
OG00627.3(6.9 to 53.4)
OG00742.6(17.7 to 65.7)
36.71
± 21
OG00475.91± 18
OG005268.1± 20
OG0068.264± 25
OG00772.05± 22
Participants
OG004
9
ParticipantsOG0053
ParticipantsOG00615
ParticipantsOG00716
Title
Measurements
OG0012.731± 54
OG00211.03± 23
OG00356.15± 19
OG004114.9± 22
OG005401.1± 26
OG00610.27± 32
OG007105.7± 23
6218
± 23
OG00412810± 17
OG00538220± 19
OG0061375± 25
OG00714360± 19
Participants
OG004
8
ParticipantsOG0053
ParticipantsOG00614
ParticipantsOG00715
Title
Measurements
OG001299± 151
OG0022072± 36
OG00311610± 18
OG00425600± 21
OG00582710± 32
OG0062236± 37
OG00725380± 29
NA
± NA
Geometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 1580,991.
OG00722700± NAGeometric CV was not calculated for n\<3.
Participants
OG004
1
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0071
Title
Measurements
OG001380.7± 56
OG00433800± NAGeometric CV was not calculated for n\<3.
OG0061180± NAGeometric CV was not calculated for n\<3.
OG00735000± NAGeometric CV was not calculated for n\<3.
5.67
± 5.89
OG00711.9± NAGeometric CV was not calculated for n\<3.
Participants
OG004
1
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0071
Title
Measurements
OG0014.010± 1.1370
OG00410.6± NAGeometric CV was not calculated for n\<3.
OG0065.76± NAGeometric CV was not calculated for n\<3.
OG00711.9± NAGeometric CV was not calculated for n\<3.
2
OG0040
OG0050
OG0067
OG0070
ParticipantsOG00412
ParticipantsOG0053
ParticipantsOG00616
ParticipantsOG00719
Title
Measurements
OG0000
OG0013
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
41.53
± 11.797
OG00448.45± 18.597
OG00547.60± 12.181
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00033.60± 34.083
OG0012.10± 2.621
OG0020.53± 0.869
OG00311.96± 26.576
OG0040.40± 1.047
OG005-0.25± 0.507
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG00035.60± 31.961
OG0012.19± 1.297
OG0021.08± 0.859
OG003-0.07± 0.221
OG0040.10± 0.469
OG0050.10± 0.141
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00053.90± 21.355
OG0016.21± 6.127
OG0020.94± 1.250
OG0030.30± 0.306
OG0040.70± 1.724
OG005-0.00± 0.294
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG00032.30± 11.738
OG00115.21± 11.219
OG0023.67± 2.511
OG0030.41± 0.745
OG0040.88± 1.881
OG005-0.03± 0.153
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00046.35± 11.950
OG00110.00± 6.387
OG0021.26± 1.367
OG0030.04± 0.098
OG0040.24± 0.720
OG005-0.03± 0.058
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00049.25± 21.708
OG00127.44± 24.644
OG0022.39± 3.102
OG0030.04± 0.223
OG0040.56± 0.940
OG005-0.20± 0.424
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00035.15± 35.426
OG00117.42± 18.026
OG0021.03± 2.177
OG0030.04± 0.151
OG0040.44± 1.043
OG005-0.27± 0.379
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00019.00± NAThere was only one participant with an assessment of free CD4+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00122.54± 20.118
OG0020.44± 0.391
OG003-0.07± 0.153
OG0040.57± 1.069
OG0050.20± 0.283
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00124.3± 15.719
OG0020.67± 0.603
OG0030.10± NAThere was only one participant with an assessment of free CD4+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0040.80± 1.386
OG005-0.25± 0.354
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG00053.20± 1.838
OG00131.13± 22.871
OG0020.23± 0.252
OG003-0.18± 0.150
OG0040.85± 1.061
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00066.95± 22.698
OG00157.26± 18.236
OG00255.18± 10.939
OG00345.67± 12.565
OG00442.72± 9.957
OG00549.25± 15.295
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00046.55± 41.366
OG0013.41± 2.948
OG0020.65± 0.771
OG00312.92± 28.499
OG0040.13± 0.333
OG0050.08± 0.222
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG00044.35± 36.275
OG0016.33± 5.863
OG0022.70± 3.344
OG0030.10± 0.238
OG0040.01± 0.107
OG005-0.05± 0.071
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00061.40± 21.072
OG00111.50± 8.179
OG0021.34± 1.646
OG0030.66± 1.037
OG0040.42± 0.624
OG0050.08± 0.222
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG00051.55± 0.495
OG00120.17± 12.575
OG0024.83± 3.810
OG0031.13± 1.908
OG0040.58± 0.697
OG005-0.10± 0.173
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00054.70± 20.648
OG00119.42± 10.402
OG0022.91± 2.195
OG0030.23± 0.390
OG0040.14± 0.385
OG0050.30± 0.458
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00060.20± 24.183
OG00132.47± 23.479
OG0023.49± 4.759
OG0030.37± 0.556
OG0040.16± 0.422
OG005-0.05± 0.071
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00045.95± 41.083
OG00124.00± 18.939
OG0022.99± 4.632
OG0030.11± 0.393
OG0040.18± 0.349
OG005-0.03± 0.115
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00021.10± NAThere was only one participant with an assessment of free CD4+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00124.52± 22.304
OG0021.98± 1.096
OG0030.13± 0.231
OG0040.17± 0.289
OG0050.15± 0.071
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00132.88± 16.059
OG0021.77± 1.966
OG0030.00± NAThere was only one participant with an assessment of free CD4+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0040.37± 0.635
OG005-0.15± 0.071
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG00058.05± 9.263
OG00147.80± 21.140
OG0020.27± 0.351
OG0030.15± 0.436
OG0040.50± 0.424
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0008.20± 0.566
OG0019.77± 11.267
OG0025.50± 4.018
OG00312.52± 8.946
OG0048.95± 6.649
OG00518.73± 18.566
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0003.40± 4.384
OG0010.04± 0.730
OG0020.65± 0.909
OG0033.50± 7.275
OG0041.13± 1.997
OG0050.28± 0.457
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG0003.90± 1.273
OG0010.59± 1.415
OG0020.23± 0.674
OG0030.03± 1.021
OG0040.17± 0.836
OG005-0.20± 0.141
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0003.20± 1.273
OG0013.01± 4.378
OG0020.54± 1.381
OG003-0.23± 0.699
OG0041.13± 3.862
OG005-0.00± 0.408
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG0002.75± 3.465
OG0013.91± 2.967
OG0020.19± 0.937
OG0030.31± 0.825
OG0041.67± 4.089
OG005-0.20± 0.985
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0004.50± 0.566
OG0013.08± 2.994
OG0020.31± 0.965
OG003-0.20± 0.673
OG0041.20± 3.333
OG0050.50± 0.600
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0005.40± 5.091
OG0016.81± 7.484
OG0020.03± 0.699
OG003-0.26± 0.616
OG0041.52± 3.702
OG005-0.40± 0.707
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0003.00± 1.838
OG0015.35± 4.214
OG0020.53± 0.647
OG003-0.24± 1.086
OG0040.44± 1.205
OG005-0.87± 0.681
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0000.90± NAThere was only one participant with an assessment of free CD8+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0015.06± 5.735
OG002-0.46± 1.561
OG003-0.03± 0.231
OG0044.63± 8.372
OG005-0.45± 0.212
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0016.55± 5.978
OG0020.63± 1.274
OG0030.40± NAThere was only one participant with an assessment of free CD8+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0041.90± 3.897
OG005-0.60± 0.707
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG0006.10± 6.647
OG0019.80± 11.895
OG002-0.07± 0.115
OG003-0.27± 1.396
OG0043.55± 5.445
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0002.55± 0.778
OG0013.14± 2.932
OG0022.05± 1.993
OG0034.57± 2.953
OG0043.15± 2.473
OG0057.23± 8.066
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0001.90± 0.849
OG0010.06± 0.360
OG0020.07± 0.216
OG0031.40± 2.859
OG0040.57± 1.537
OG0050.08± 0.050
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG0001.05± 0.495
OG0010.36± 0.519
OG0020.05± 0.105
OG0030.04± 0.151
OG0040.41± 1.057
OG005-0.10± 0.000
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0001.40± 0.283
OG0010.50± 0.306
OG002-0.01± 0.146
OG0030.03± 0.198
OG0040.93± 2.647
OG0050.00± 0.082
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG0001.85± 2.192
OG0012.01± 2.507
OG0020.04± 0.181
OG0030.01± 0.090
OG0041.37± 3.300
OG0050.00± 0.100
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0003.20± 2.404
OG0011.10± 0.868
OG0020.06± 0.172
OG0030.06± 0.127
OG0040.88± 2.080
OG0050.07± 0.153
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0002.75± 1.909
OG0012.90± 2.725
OG0020.17± 0.309
OG003-0.01± 0.135
OG0040.32± 0.939
OG005-0.25± 0.212
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0000.65± 0.636
OG0012.50± 2.571
OG0020.01± 0.107
OG003-0.06± 0.113
OG0040.86± 1.596
OG0050.00± 0.100
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0002.20± NAThere was only one participant with an assessment of free CD8+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0013.06± 5.099
OG0020.12± 0.164
OG003-0.07± 0.115
OG0042.40± 4.244
OG0050.15± 0.071
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0014.28± 4.129
OG0020.27± 0.462
OG0030.20± NAThere was only one participant with an assessment of free CD8+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0041.13± 1.966
OG005-0.10± 0.000
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG0002.05± 1.202
OG0014.77± 7.218
OG0020.30± 0.624
OG003-0.05± 0.058
OG0041.00± 1.414
7
ParticipantsOG0048
ParticipantsOG0054
Title
Measurements
OG00028.85± 0.778
OG00140.18± 12.164
OG00234.51± 10.649
OG00342.13± 18.565
OG00441.98± 12.160
OG00538.35± 9.019
9
ParticipantsOG0048
ParticipantsOG0054
Title
Measurements
OG00026.85± 0.212
OG00136.30± 10.886
OG00234.46± 11.679
OG00342.89± 13.179
OG00440.23± 8.245
OG00540.55± 9.219
8
ParticipantsOG0047
ParticipantsOG0053
Title
Measurements
OG00031.30± 1.980
OG00135.28± 14.278
OG00234.92± 5.867
OG00340.88± 11.313
OG00445.69± 6.950
OG00538.43± 6.543
8
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00027.55± 3.606
OG00140.33± 15.040
OG00238.21± 4.342
OG00343.15± 9.439
OG00452.44± 5.264
OG00535.77± 14.935
9
ParticipantsOG0046
ParticipantsOG0052
Title
Measurements
OG00028.85± 2.758
OG00139.14± 12.053
OG00233.46± 11.820
OG00337.88± 11.844
OG00444.57± 13.038
OG00539.25± 20.718
9
ParticipantsOG0047
ParticipantsOG0053
Title
Measurements
OG00030.40± 0.566
OG00134.08± 8.806
OG00232.47± 13.862
OG00338.61± 13.391
OG00441.61± 11.904
OG00541.10± 15.125
5
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00034.40± NAThere was only one participant with an assessment of total, CD127lo regulatory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00136.50± 6.840
OG00236.40± 4.627
OG00332.20± 7.105
OG00441.88± 12.275
OG00535.85± 0.354
2
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00138.64± 5.538
OG00235.20± 3.350
OG00325.70± 9.051
OG00445.23± 9.955
OG00548.25± 12.799
5
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG00035.30± 2.404
OG00134.00± 16.913
OG00228.12± 16.961
OG00338.10± 10.006
OG00445.20± 10.611
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00049.90± 3.536
OG00150.61± 16.877
OG00244.38± 9.798
OG00345.35± 13.300
OG00452.28± 16.746
OG00533.23± 16.607
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00056.45± 6.010
OG00152.19± 16.212
OG00248.00± 14.287
OG00351.86± 10.272
OG00444.77± 24.667
OG00536.05± 16.733
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG00052.85± 11.384
OG00152.74± 14.199
OG00248.67± 8.943
OG00339.77± 12.347
OG00445.11± 21.747
OG00521.00± 4.101
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00049.75± 18.880
OG00146.47± 14.885
OG00239.07± 13.011
OG00345.09± 10.489
OG00438.22± 20.166
OG00527.70± 13.124
7
ParticipantsOG0048
ParticipantsOG0053
Title
Measurements
OG00049.90± 9.758
OG00141.43± 14.750
OG00241.21± 9.855
OG00345.70± 10.567
OG00445.17± 16.509
OG00523.30± 11.811
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00050.85± 8.132
OG00149.08± 20.277
OG00246.00± 7.485
OG00341.00± 12.981
OG00434.40± 17.363
OG00523.27± 26.999
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00049.75± 13.223
OG00150.04± 13.227
OG00240.76± 18.801
OG00342.94± 11.357
OG00437.22± 19.773
OG00535.65± 31.183
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00054.95± 8.839
OG00145.20± 16.005
OG00241.20± 20.054
OG00342.87± 10.049
OG00439.30± 13.509
OG00537.37± 16.783
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00037.20± NAThere was only one participant with an assessment of total CD4+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00147.52± 15.688
OG00241.42± 11.115
OG00343.43± 5.788
OG00430.37± 15.309
OG00532.15± 19.304
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00153.80± 9.098
OG00236.67± 2.589
OG00339.90± NAThere was only one participant with an assessment of total CD4+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00427.27± 23.200
OG00549.00± 27.294
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG00052.75± 13.789
OG00146.70± 12.775
OG00224.80± 23.435
OG00341.38± 6.111
OG00434.65± 11.526
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00059.60± 16.546
OG00156.10± 15.093
OG00243.38± 23.693
OG00347.03± 13.816
OG00440.25± 12.277
OG00541.58± 15.879
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00060.65± 17.607
OG00158.76± 16.535
OG00250.53± 13.385
OG00347.82± 15.437
OG00431.28± 15.021
OG00538.68± 19.538
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG00057.00± 19.658
OG00159.39± 15.181
OG00252.93± 9.347
OG00337.09± 14.705
OG00431.91± 17.122
OG00524.25± 19.728
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00056.20± 18.526
OG00150.57± 12.243
OG00245.09± 11.917
OG00344.00± 13.558
OG00431.87± 18.013
OG00533.43± 10.754
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG00058.45± 18.173
OG00149.54± 12.391
OG00251.86± 9.906
OG00344.06± 12.694
OG00435.20± 14.024
OG00530.40± 12.382
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00056.40± 15.274
OG00162.78± 19.629
OG00251.01± 14.110
OG00343.93± 14.824
OG00433.48± 21.662
OG00531.60± 21.458
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00056.50± 18.526
OG00156.11± 14.652
OG00246.63± 22.926
OG00343.71± 14.276
OG00435.08± 19.484
OG00542.35± 21.708
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00060.85± 15.344
OG00151.48± 21.069
OG00245.60± 23.497
OG00342.40± 13.966
OG00441.88± 16.112
OG00531.67± 18.151
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00044.00± NAThere was only one participant with an assessment of total CD4+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00149.92± 11.834
OG00248.54± 14.165
OG00351.03± 10.119
OG00429.60± 7.754
OG00533.40± 30.830
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00155.98± 10.071
OG00238.67± 12.438
OG00344.80± NAThere was only one participant with an assessment of total CD4+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00422.10± 18.857
OG00559.75± 12.092
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG00062.50± 20.789
OG00163.00± 21.165
OG00221.43± 17.010
OG00329.83± 12.258
OG00436.80± 12.869
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0007.55± 4.879
OG00112.00± 10.795
OG0029.02± 5.270
OG00316.30± 11.546
OG00412.82± 4.961
OG00515.63± 20.503
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG00010.35± 6.859
OG00111.34± 11.046
OG0029.00± 5.355
OG00318.72± 14.591
OG00410.03± 8.477
OG00515.23± 15.784
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG0007.30± 5.940
OG00110.33± 9.138
OG0028.65± 6.783
OG00312.27± 10.298
OG00411.93± 8.826
OG00523.95± 34.295
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0004.50± 1.131
OG0019.53± 7.607
OG0029.03± 10.168
OG00315.81± 9.926
OG0049.55± 7.987
OG00510.65± 15.910
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG0008.70± 7.495
OG0019.56± 10.163
OG0029.50± 12.278
OG00314.83± 11.588
OG00410.42± 7.695
OG0052.67± 1.570
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0008.70± 5.798
OG00112.13± 11.505
OG00210.19± 13.521
OG00312.89± 8.212
OG00410.38± 10.295
OG0052.77± 3.109
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0006.05± 4.738
OG00112.11± 7.990
OG00210.49± 11.153
OG00314.19± 9.905
OG0049.86± 9.571
OG0056.20± 4.525
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0006.05± 1.626
OG00111.55± 8.232
OG00211.29± 13.434
OG00313.90± 8.309
OG00410.34± 8.769
OG0053.00± 1.900
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0005.90± NAThere was only one participant with an assessment of total CD8+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not be calculated.
OG00111.54± 10.077
OG00213.42± 8.546
OG00313.60± 10.942
OG00412.07± 12.360
OG0054.75± 3.041
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00116.35± 10.850
OG0028.03± 1.528
OG00321.60± NAThere was only one participant with an assessment of total CD8+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation valuewas not calculated.
OG00411.97± 12.051
OG0056.30± 2.263
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG0006.85± 3.182
OG00113.77± 10.845
OG0023.87± 5.065
OG00315.08± 12.687
OG0049.90± 13.576
6
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0003.35± 2.051
OG0013.66± 3.062
OG0023.25± 2.091
OG0035.35± 4.700
OG0043.82± 3.207
OG00524.48± 26.779
5
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0003.80± 1.697
OG0014.31± 3.611
OG0022.67± 2.081
OG0034.86± 5.229
OG0042.80± 3.454
OG00522.53± 26.873
7
ParticipantsOG0047
ParticipantsOG0052
Title
Measurements
OG0002.60± 0.990
OG0015.19± 3.873
OG0022.73± 2.004
OG0033.57± 4.130
OG0043.14± 3.347
OG00511.70± 15.839
7
ParticipantsOG0046
ParticipantsOG0054
Title
Measurements
OG0002.60± 1.273
OG0013.54± 2.463
OG0023.36± 5.108
OG0034.50± 4.727
OG0042.57± 3.222
OG00517.88± 20.990
7
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG0003.25± 2.616
OG0014.70± 4.031
OG0023.77± 6.125
OG0034.53± 4.511
OG0043.12± 3.539
OG00513.10± 19.341
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0002.65± 0.778
OG0013.90± 3.524
OG0023.56± 5.524
OG0034.06± 4.008
OG0044.16± 5.786
OG00519.07± 30.641
7
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0002.50± 1.697
OG0015.14± 4.446
OG0023.69± 5.607
OG0034.33± 3.693
OG0043.14± 3.884
OG00530.45± 38.537
7
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG0002.70± 0.990
OG0014.48± 4.388
OG0023.50± 5.568
OG0034.57± 4.340
OG0043.64± 3.832
OG00518.67± 27.050
3
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0003.00± NAThere was only one participant with an assessment of total CD8+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0014.66± 5.283
OG0025.94± 5.734
OG0038.23± 4.900
OG0043.33± 5.024
OG0052.60± 0.990
1
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG0016.18± 4.811
OG0022.60± 1.952
OG0037.80± NAThere was only one participant with an assessment of total CD8+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.
OG0043.67± 5.755
OG00535.40± 46.528
4
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG0001.70± 0.141
OG0013.93± 4.957
OG0020.57± 0.306
OG0031.95± 1.605
OG0041.25± 1.061
7
ParticipantsOG0048
ParticipantsOG0054
Title
Measurements
OG00034.10± 0.283
OG00140.98± 10.428
OG00238.67± 8.521
OG00341.20± 16.148
OG00446.55± 10.978
OG00541.18± 8.761
9
ParticipantsOG0048
ParticipantsOG0054
Title
Measurements
OG00027.15± 4.172
OG00139.53± 7.635
OG00237.20± 8.902
OG00344.29± 11.058
OG00444.80± 7.508
OG00542.40± 7.165
8
ParticipantsOG0047
ParticipantsOG0053
Title
Measurements
OG00035.70± 5.940
OG00142.29± 13.590
OG00236.97± 7.219
OG00345.23± 11.181
OG00449.74± 10.086
OG00540.57± 3.415
8
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG00030.95± 3.465
OG00144.45± 14.962
OG00240.53± 6.707
OG00346.71± 10.444
OG00456.66± 12.388
OG00539.93± 16.671
9
ParticipantsOG0046
ParticipantsOG0052
Title
Measurements
OG00031.50± 9.051
OG00142.69± 14.259
OG00235.62± 13.117
OG00342.36± 9.707
OG00450.30± 10.907
OG00546.75± 19.728
9
ParticipantsOG0047
ParticipantsOG0053
Title
Measurements
OG00034.30± 3.536
OG00138.83± 8.536
OG00235.78± 13.922
OG00341.69± 10.489
OG00447.16± 13.427
OG00541.70± 13.089
5
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00035.30± NAThere was only one participant with an assessment of total FOXP3+ regulatory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.
OG00138.83± 8.658
OG00241.89± 10.092
OG00335.78± 10.316
OG00446.00± 11.665
OG00555.70± 14.001
2
ParticipantsOG0043
ParticipantsOG0052
Title
Measurements
OG00141.80± 3.149
OG00241.23± 6.725
OG00328.70± 0.849
OG00443.40± 5.145
OG00552.35± 15.344
5
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG00038.50± 3.960
OG00137.88± 15.626
OG00235.60± 19.987
OG00343.94± 10.685
OG00448.57± 7.596
0
OG0040
OG0053.3
43.8
(11.8 to 72.7)
OG00411.3(0.6 to 39.1)
OG00551.9(31.8 to 68.8)
NA
(NA to NA)
Number and ranges for 95% CI were not estimable due to all 11 participants in the group have been censored or died before month 24.
OG00411.3(0.6 to 39.1)
OG0056.7(0.5 to 25.1)
19.63
± 26
OG00462.45± 31
OG00510.20± 24
Participants
OG004
7
ParticipantsOG00526
Title
Measurements
OG0002.779± 29
OG0019.049± 21
OG0029.359± 31
OG00319.76± 45
OG00481.49± 51
OG00510.53± 39
3089
± 19
OG00410100± 19
OG0051624± 30
Participants
OG004
5
ParticipantsOG00522
Title
Measurements
OG000340.2± 73
OG0011739± 26
OG0022239± 18
OG0034034± 35
OG00419190± 48
OG0052291± 45
9480
± NA
Geometric CV was not calculated for n\<3.
OG0051657± 22
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG000NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 257,228.
OG0032710± NAGeometric CV was not calculated for n\<3.
OG0051130± NAGeometric CV was not calculated for n\<3.
5.61
± NA
Standard Deviation was not calculated for n\<3.
OG0055.260± 0.76772
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG000NA± NAMean and Standard Deviation was not calculated for n\<3. And the individual values were 2.72,3.16.
OG0034.72± NAStandard Deviation was not calculated for n\<3.
OG0053.87± NAStandard Deviation was not calculated for n\<3.
17.63
± 33
OG00419.02± 29
OG0053.232± 22
Participants
OG004
6
ParticipantsOG00526
Title
Measurements
OG0002.909± 47
OG0012.554± 79
OG00220.02± 22
OG00317.94± 39
OG00417.84± 54
OG0052.726± 47
2289
± 25
OG0042839± 15
OG005561.8± 53
Participants
OG004
4
ParticipantsOG00521
Title
Measurements
OG000NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 916,464.
OG001343.7± 225
OG0022765± 77
OG003673.9± 1191
OG0042621± 31
OG005232.1± 1524
2252
± 34
OG0043137± 15
OG005626.4± 47
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG000467± NAGeometric CV was not calculated for n\<3.
OG0031950± NAGeometric CV was not calculated for n\<3.
OG004NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 2360,2970.
OG005NA± NAGeometric Mean and Geometric CV was not calculated for n\<3. And the individual values were 624,725.
6.873
± 1.9954
OG0048.27± 2.2945
OG0056.632± 2.5566
Participants
OG004
2
ParticipantsOG0052
Title
Measurements
OG0005.25± NAStandard Deviation was not calculated for n\<3.
OG0032.59± NAStandard Deviation was not calculated for n\<3.
OG004NA± NAMean and Standard Deviation was not calculated for n\<3. And the individual values were 13,3.88.
OG005NA± NAMean and Standard Deviation was not calculated for n\<3. And the individual values were 5.76,5.8.