Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In... | NCT02501902 | Trialant
NCT02501902
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 6, 2021Actual
Enrollment
76Actual
Phase
Phase 1
Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Interventions
Palbociclib
Nab-Paclitaxel
Countries
United States
Spain
Protocol Section
Identification Module
NCT ID
NCT02501902
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A5481059
Secondary IDs
ID
Type
Description
Link
2015-001307-31
EudraCT Number
Brief Title
Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
Official Title
AN OPEN-LABEL PHASE IB STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS ABRAXANE (REGISTERED) (NAB-PACLITAXEL) IN PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2021
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
Nov 23, 2015Actual
Primary Completion Date
Oct 10, 2018Actual
Completion Date
Dec 27, 2018Actual
First Submitted Date
Jul 14, 2015
First Submission Date that Met QC Criteria
Jul 15, 2015
First Posted Date
Jul 17, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 4, 2019
Results First Submitted that Met QC Criteria
Mar 10, 2021
Results First Posted Date
Apr 6, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 10, 2021
Last Update Posted Date
Apr 6, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Celgene
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately 30-60 patients are expected to be enrolled in the overall study.
Detailed Description
The study has 2 parts:
• Part A (Dose-Escalation Cohorts): Consecutive cohorts of patients will receive escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles, in order to estimate the MTD(s) of the combination. The starting doses will be 75 mg palbociclib, and 100 mg/m2 nab-P. The observation period for dose-limiting toxicities (DLTs) will be from Day 1 to Day 28. Pharmacokinetic (PK) and pharmacodynamic (PD) properties of palbociclib and nab-P will also be assessed. Up to approximately 30 patients will be enrolled. The criteria for dose escalation will be based on a modified toxicity probability interval (mTPI) method.
• Part B [MTD Expansion Cohort(s)]: When the MTD(s) of palbociclib plus nab-P has been estimated with confidence, enrollment will proceed into 1 or 2 MTD expansion cohort(s) of up to 20 patients each at the MTD(s). The objective of the MTD expansion cohort(s) will be to provide additional information on safety, tolerability, biomarkers, PD activity, and PK/PD relationship for the combination regimen in order to determine the RP2D. The MTD expansion cohort(s) will only enroll patients who have not received previous treatment for their metastatic disease in order to evaluate preliminary activity of the combination in the target patient population.
All patients (in Part A and B) will receive nab-P intravenously once weekly for 3 weeks out of each 28-day cycle. Palbociclib oral dosing will be once daily on Days 1-21 of each 28-day cycle. To allow for PK evaluation of nab-P administered alone, nab-P will be administered on Day -2 for Cycle 1 only. Subsequent cycles will administer both nab-P and palbociclib on Day 1. Alternate dosing schedules for palbociclib may be explored based on emerging PK, PD, and safety data.
Patients will be treated as long as they are clinically benefiting from investigational product without unacceptable toxicity, objective disease progression, or withdrawal of consent. A modified visit schedule will be implemented for patients who are on investigational product for more than 2 years.
Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle. Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.
Drug: Palbociclib
Drug: Nab-Paclitaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Palbociclib
Drug
Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle.
Palbociclib + Nab-Paclitaxel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities
Adverse events (AEs) considered as dose limiting toxicities (DLTs) included: hematologic: Grade 4 neutropenia lasting >4 days; Febrile neutropenia (defined as neutropenia Grade>=3 [absolute neutrophil count {ANC}<1000 cells/cubic millimeter {mm^3}] and a body temperature >=38.5 [degrees centigrade]℃) requiring antibiotic or antifungal treatment; any Grade 4 thrombocytopenia (<25000/mm^3 or 25.0*10^9/[liter]L). Non-hematologic: Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea). Any AE that caused a palbociclib treatment interruption of greater than 7 consecutive days or caused any combination of interruption/reduction for >=14 days. Any AE that caused omission or reduction of at least 2 of the 3 weekly doses of nab-P.
From Day 1 until pre-dose Cycle 2 Day 1
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product. Disease progression was not considered a treatment emergent AE unless the participant died of disease prior to 28 days after discontinuation of treatment. Treatment emergent AEs with cause possibly, probably or definitely related to treatment, as judged by the investigator, were defined as treatment-related AEs. AEs were graded by investigator according to CTCAE v4.03.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma.
Availability of a tumor tissue specimen. If no archived tumor tissue is available, then a de novo biopsy is required for patient participation.
Karnofsky Performance Status 70 or greater.
Adequate Bone Marrow, Renal, and Liver Function.
Exclusion Criteria:
Prior treatment with a CDK 4/6 inhibitor.
Prior treatment with nab-P for the treatment of metastatic disease.
Patients with known CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
Diagnosis of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
QTc >480 msec, or family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
Uncontrolled electrolyte disorders.
Cardiac or pulmonary disorders within 6 months of enrollment.
Known human immunodeficiency virus infection.
History of interstitial lung disease or pneumonitis.
Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-P.
Difficulty swallowing capsules or requirement for a feeding tube.
Pregnant female patients; breastfeeding female patients; male patients with partners currently pregnant.
Active inflammatory or other gastrointestinal disease,
Active bleeding disorder in the past 6 months.
Patients treated within the last 7 days prior to the start of IP with strong/moderate CYP3A4 inhibitors, strong/moderate CYP3A4 inducers, CYP2C8 inhibitors, strong/moderate CYP2C8 inducers, or drugs that are known to prolong the QT interval.
Hidalgo M, Garcia-Carbonero R, Lim KH, Messersmith WA, Garrido-Laguna I, Borazanci E, Lowy AM, Medina Rodriguez L, Laheru D, Salvador-Barbero B, Malumbres M, Shields DJ, Grossman JE, Huang X, Tammaro M, Martini JF, Yu Y, Kern K, Macarulla T. A Preclinical and Phase Ib Study of Palbociclib plus Nab-Paclitaxel in Patients with Metastatic Adenocarcinoma of the Pancreas. Cancer Res Commun. 2022 Nov 2;2(11):1326-1333. doi: 10.1158/2767-9764.CRC-22-0072. eCollection 2022 Nov.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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
This was a multiple dose, dose escalation study of palbociclib in combination with nab-paclitaxel (nab-P), in sequential cohorts of adult participants.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
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
5
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
SAP
No
Yes
No
Statistical Analysis Plan
Dec 6, 2018
Oct 4, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Ibrance
Nab-Paclitaxel
Drug
Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.
Palbociclib + Nab-Paclitaxel
Abraxane
From the signing of informed consent up to 56 days after the last administration of the investigational product, or 365 days from the first dose of investigational product, whichever is later
Number of Participants With Laboratory Abnormalities
The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to NCI CTCAE v4.0 were summarized: hematology (anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils, platelets and white blood cells) and chemistry laboratory tests (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglocemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase).
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Vital signs evaluation included sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse rate. Suggest text: Vital signs categorical summary included: 1)SBP>150mmHg or DBP>100mmHg; 2)SBP>200mmHg or DBP>110mmHg; 3)SBP increase >=20 and <40mmHg; 4)SBP increase >=40 and <60mmHg; 5)SBP increase>=60mmHg; 6)DBP increase >=10 and <20mmHg; 7)DBP increase >=20 and <30mmHg; 8)DBP increase >=30mmHg; 9)pulse rate>120bpm; 10)pulse rate<50bpm.
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With 20% Maximum Reduction From Baseline in Ca19-9
Carbohydrate antigen 19-9 (Ca19-9) is a clinical pharmacodynamic (PD) marker associated with metastatic pancreatic ductal adenocarcinoma (mPDAC).
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With 50% Maximum Reduction From Baseline in Ca19-9
Ca19-9 is a clinical PD marker associated with metastatic mPDAC.
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With 70% Maximum Reduction From Baseline in Ca19-9
Ca19-9 is a clinical PD marker associated with metastatic mPDAC.
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With 90% Maximum Reduction From Baseline in Ca19-9
Ca19-9 is a clinical PD marker associated with metastatic mPDAC.
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Objective Response Rate
Percentage of participants who achieved objective response (OR) based on investigator assessment is presented. OR is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Objective response rate (ORR) was defined as the percentage of participants with a best overall response of CR or PR relative to all anti-tumor evaluable participants.
From screening to 365 days from the last dose of investigational product
Duration of Response
The duration of response was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
From screening to 365 days from the last dose of investigational product
Progression Free Survival
The progression free survival (PFS) was defined as the time from the date of first dose to the date of the first documentation of objective tumor progression as per RECIST v1.1 or death due to any cause in the absence of documented progression disease, whichever occurred first.
From screening to 365 days from the last dose of investigational product
6m-PFS was defined as PFS status (progression free and alive, or not) at Month 6. It was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.
From screening to 6 months after first dose of investigational product
Overall Survival (OS)
OS was defined as the time from the date of first dose to the date of death due to any cause. Following the end of treatment visit, survival status was collected in all participants every month until 12 months (365 days) had elapsed from the last dose of investigational product.
From screening to 365 days from the last dose of investigational product
Number of Participants With Positive p16
p16 is a tumor suppressor protein which plays an important role in cell cycle regulation. The analysis of biomarker p16 expression might aid in the identification of patient subpopulations most likely to benefit from treatment. The results from p16 expression testing by immunohistochemistry (IHC) was used for sensitivity analyses. (a) and (b) :p16 cutoff utilizing the optimal cut point identified by the ORC analysis for the OS (a) or PFS (b) and the p16 positive tumor cells.
From Day-2 to up to 63 days from last dose of investigational product
Retinoblastoma Protein (Rb) Percent Positive Cell (Nuclear Staining)
Rb is a tumor suppressor protein that is dysfunctional in several major cancers. The results from Rb expression testing by IHC was used for sensitivity analyses.
From Day-2 to up to 63 days from last dose of investigational product
Rb H-score Nuclear Staining
Rb is a tumor suppressor protein that is dysfunctional in several major cancers. The results from Rb expression testing by IHC was used for sensitivity analyses. The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors. The score is obtained by the formula: 3*percentage of strongly staining nuclei + 2*percentage of moderately staining nuclei + percentage of weakly staining nuclei, giving the range of 0 to 300
From Day-2 to up to 63 days from last dose of investigational product
Palbociclib Multiple Dose Maximum Plasma Concentration (Cmax)
The palbociclib multiple dose maximum plasma concentration(Cmax) was observed directly from data.
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
Palbociclib Multiple Dose Time for Cmax (Tmax)
The palbociclib multiple dose time for Cmax (Tmax) was observed directly from data.
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
Palbociclib Area Under the Plasma Concentration-time Curve for Dosing Interval τ (AUCτ)
The palbociclib area under the plasma concentration-time curve for dosing interval τ (AUCτ) was observed directly from data.
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
The palbociclib multiple dose apparent clearance (CL/F) was observed directly from data.
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
Nab-P Cmax
The nab-P Cmax on Cycle 1 Day -1 and Day 13 were observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
Nab-P Tmax
The nab-P Tmax on Day -1 and Day 13 were observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
Nab-P Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration (AUClast)
The nab-P area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) on Day -1 and Day 13 were observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
Nab-P Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
The nab-P area under the plasma concentration-time curve from time 0 extrapolated to infinite time (AUCinf) on Day -1 and Day 13 observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
The nab-P t1/2 on Day -1 and Day 13 were observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
Nab-P Clearance (CL)
The nab-P clearance on Day -1 and Day 13 were observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
Nab-P Volume of Distribution (Vz)
The nab-P on Day -1 and Day 13 were observed directly from data.
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
Scottsdale
Arizona
85258
United States
UC San Diego Medical Center - La Jolla (Thornton Hospital)
La Jolla
California
92037-0845
United States
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla
California
92037-0845
United States
UC San Diego Moores Cancer Center
La Jolla
California
92093
United States
UC San Diego Medical Center - Hillcrest
San Diego
California
92103
United States
Anschutz Cancer Pavilion
Aurora
Colorado
80045
United States
University of Colorado Cancer Center
Aurora
Colorado
80045
United States
University of Colorado Denver, CTO (CTRC)
Aurora
Colorado
80045
United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora
Colorado
80045
United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora
Colorado
80045
United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Maryland
21231-1000
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Siteman Cancer Center
City of Saint Peters
Missouri
63376
United States
Siteman Cancer Center - West County
Creve Coeur
Missouri
63141
United States
Barnes-Jewish Hospital
St Louis
Missouri
63110
United States
Washington University Infusion Center Pharmacy
St Louis
Missouri
63110
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Siteman Cancer Center - South County
St Louis
Missouri
63129
United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City
Utah
84112
United States
University of Utah, Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Hospital Universitario de Fuenlabrada. Unidad de Farmacia
Fuenlabrada
Madrid
28942
Spain
Hospital Universitario Fuenlabrada
Fuenlabrada
Madrid
28942
Spain
Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica
Barcelona
08035
Spain
Hospital Universitario 12 de Octubre Servicio de Farmacia
Madrid
28041
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
FG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
FG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
FG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100 mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
FG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
FG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
FG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
FG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
FG0003 subjects
FG0017 subjects
FG0024 subjects
FG00311 subjects
FG00411 subjects
FG00511 subjects
FG0069 subjects
FG00720 subjects
COMPLETED
0
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0024 subjects
FG00311 subjects
FG00411 subjects
FG00511 subjects
FG0069 subjects
FG00720 subjects
Type
Comment
Reasons
Subject Refused Further Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Study Terminated by Sponsor
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG00310 subjects
FG004
The baseline analysis population included all participants enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DL1 Palbociclib 75 mg/Nab-Paclitaxel 100 mg /m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-paclitaxel 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
BG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
BG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
BG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100 mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
BG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
BG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
BG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
BG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0017
BG0024
BG00311
BG00411
BG00511
BG0069
BG00720
BG00876
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<18
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0003
BG0016
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
Adverse events (AEs) considered as dose limiting toxicities (DLTs) included: hematologic: Grade 4 neutropenia lasting >4 days; Febrile neutropenia (defined as neutropenia Grade>=3 [absolute neutrophil count {ANC}<1000 cells/cubic millimeter {mm^3}] and a body temperature >=38.5 [degrees centigrade]℃) requiring antibiotic or antifungal treatment; any Grade 4 thrombocytopenia (<25000/mm^3 or 25.0*10^9/[liter]L). Non-hematologic: Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea). Any AE that caused a palbociclib treatment interruption of greater than 7 consecutive days or caused any combination of interruption/reduction for >=14 days. Any AE that caused omission or reduction of at least 2 of the 3 weekly doses of nab-P.
The analysis population included all participants who received at least 1 dose of either investigational product and met the measurable criteria.
Posted
Count of Participants
Participants
From Day 1 until pre-dose Cycle 2 Day 1
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Secondary
Number of Participants With Adverse Events
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product. Disease progression was not considered a treatment emergent AE unless the participant died of disease prior to 28 days after discontinuation of treatment. Treatment emergent AEs with cause possibly, probably or definitely related to treatment, as judged by the investigator, were defined as treatment-related AEs. AEs were graded by investigator according to CTCAE v4.03.
The analysis population included all participants who received at least 1 dose of either investigational product.
Posted
Count of Participants
Participants
From the signing of informed consent up to 56 days after the last administration of the investigational product, or 365 days from the first dose of investigational product, whichever is later
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
Secondary
Number of Participants With Laboratory Abnormalities
The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to NCI CTCAE v4.0 were summarized: hematology (anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils, platelets and white blood cells) and chemistry laboratory tests (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglocemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase).
The analysis population included all participants who received at least 1 dose of either investigational product.
Posted
Count of Participants
Participants
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Vital signs evaluation included sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse rate. Suggest text: Vital signs categorical summary included: 1)SBP>150mmHg or DBP>100mmHg; 2)SBP>200mmHg or DBP>110mmHg; 3)SBP increase >=20 and <40mmHg; 4)SBP increase >=40 and <60mmHg; 5)SBP increase>=60mmHg; 6)DBP increase >=10 and <20mmHg; 7)DBP increase >=20 and <30mmHg; 8)DBP increase >=30mmHg; 9)pulse rate>120bpm; 10)pulse rate<50bpm.
The analysis population included all participants who received at least 1 dose of either investigational product.
Posted
Count of Participants
Participants
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Number of Participants With 20% Maximum Reduction From Baseline in Ca19-9
Carbohydrate antigen 19-9 (Ca19-9) is a clinical pharmacodynamic (PD) marker associated with metastatic pancreatic ductal adenocarcinoma (mPDAC).
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment.
Posted
Count of Participants
Participants
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG002
Secondary
Number of Participants With 50% Maximum Reduction From Baseline in Ca19-9
Ca19-9 is a clinical PD marker associated with metastatic mPDAC.
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment.
Posted
Count of Participants
Participants
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Secondary
Number of Participants With 70% Maximum Reduction From Baseline in Ca19-9
Ca19-9 is a clinical PD marker associated with metastatic mPDAC.
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment.
Posted
Count of Participants
Participants
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Secondary
Number of Participants With 90% Maximum Reduction From Baseline in Ca19-9
Ca19-9 is a clinical PD marker associated with metastatic mPDAC.
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment.
Posted
Count of Participants
Participants
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Secondary
Objective Response Rate
Percentage of participants who achieved objective response (OR) based on investigator assessment is presented. OR is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Objective response rate (ORR) was defined as the percentage of participants with a best overall response of CR or PR relative to all anti-tumor evaluable participants.
The analysis population included all participants who received at least 1 dose of either investigational product, had a baseline tumor assessment and at least 1 on-treatment tumor assessment prior to any new anti-cancer therapies. Results for groups with a small sample size should be interpreted with caution.
Posted
Number
95% Confidence Interval
Percentage of participants
From screening to 365 days from the last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Duration of Response
The duration of response was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
The analysis population included all participants who received at least 1 dose of either investigational product, had a baseline tumor assessment and at least 1 on-treatment tumor assessment prior to any new anti-cancer therapies. Results for groups with a small sample size should be interpreted with caution.
Posted
Median
95% Confidence Interval
Months
From screening to 365 days from the last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Progression Free Survival
The progression free survival (PFS) was defined as the time from the date of first dose to the date of the first documentation of objective tumor progression as per RECIST v1.1 or death due to any cause in the absence of documented progression disease, whichever occurred first.
The analysis population included all participants who received at least 1 dose of either investigational product, had a baseline tumor assessment and at least 1 on-treatment tumor assessment prior to any new anti-cancer therapies. Results for groups with a small sample size should be interpreted with caution.
Posted
Median
95% Confidence Interval
Months
From screening to 365 days from the last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
6m-PFS was defined as PFS status (progression free and alive, or not) at Month 6. It was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.
The analysis population included all participants who received at least 1 dose of either investigational product, had a baseline tumor assessment and at least 1 on-treatment tumor assessment prior to any new anti-cancer therapies. Results for groups with a small sample size should be interpreted with caution.
Posted
Number
95% Confidence Interval
Percentage of participants
From screening to 6 months after first dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Overall Survival (OS)
OS was defined as the time from the date of first dose to the date of death due to any cause. Following the end of treatment visit, survival status was collected in all participants every month until 12 months (365 days) had elapsed from the last dose of investigational product.
Participants who received study treatment, had adequate baseline assessments and at least 1 on-treatment tumor assessment prior to any new anti-cancer therapies were evaluable for anti-tumor activity. Results for groups with a small sample size should be interpreted with caution.
Posted
Median
95% Confidence Interval
Months
From screening to 365 days from the last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Number of Participants With Positive p16
p16 is a tumor suppressor protein which plays an important role in cell cycle regulation. The analysis of biomarker p16 expression might aid in the identification of patient subpopulations most likely to benefit from treatment. The results from p16 expression testing by immunohistochemistry (IHC) was used for sensitivity analyses. (a) and (b) :p16 cutoff utilizing the optimal cut point identified by the ORC analysis for the OS (a) or PFS (b) and the p16 positive tumor cells.
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment and met the criteria for measuring p16.
Posted
Count of Participants
Participants
From Day-2 to up to 63 days from last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Retinoblastoma Protein (Rb) Percent Positive Cell (Nuclear Staining)
Rb is a tumor suppressor protein that is dysfunctional in several major cancers. The results from Rb expression testing by IHC was used for sensitivity analyses.
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment and met the criteria for measuring Rb.
Posted
Mean
Standard Deviation
Percentage of positive cell
From Day-2 to up to 63 days from last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Rb H-score Nuclear Staining
Rb is a tumor suppressor protein that is dysfunctional in several major cancers. The results from Rb expression testing by IHC was used for sensitivity analyses. The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors. The score is obtained by the formula: 3*percentage of strongly staining nuclei + 2*percentage of moderately staining nuclei + percentage of weakly staining nuclei, giving the range of 0 to 300
The analysis population included all participants who received at least 1 dose of investigational product and had at least 1 baseline biomarker assessment and met the criteria for measuring Rb.
Posted
Mean
Standard Deviation
Scores on a scale
From Day-2 to up to 63 days from last dose of investigational product
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Palbociclib Multiple Dose Maximum Plasma Concentration (Cmax)
The palbociclib multiple dose maximum plasma concentration(Cmax) was observed directly from data.
The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic (PK) of interest and had no major protocol deviations affecting PK assessment. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milli liter (ng/mL)
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Palbociclib Multiple Dose Time for Cmax (Tmax)
The palbociclib multiple dose time for Cmax (Tmax) was observed directly from data.
The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic (PK) of interest and had no major protocol deviations affecting PK assessment. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Median
Full Range
hour(hr)
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Palbociclib Area Under the Plasma Concentration-time Curve for Dosing Interval τ (AUCτ)
The palbociclib area under the plasma concentration-time curve for dosing interval τ (AUCτ) was observed directly from data.
The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic (PK) of interest and had no major protocol deviations affecting PK assessment. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour per milli liter (ng.hr/mL)
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
The palbociclib multiple dose trough plasma concentration (Ctrough) was observed directly from data.
The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic (PK) of interest and had no major protocol deviations affecting PK assessment. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
The palbociclib multiple dose apparent clearance (CL/F) was observed directly from data.
The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the pharmacokinetic (PK) of interest and had no major protocol deviations affecting PK assessment. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter per hour (L/hr)
Cycle 1 Day 13 at 0 (pre-dose), 2, 4, 6, 8 and 24 hours post palbociclib dose, and pre-dose on Cycle 2, Days 1 and 15.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Nab-P Cmax
The nab-P Cmax on Cycle 1 Day -1 and Day 13 were observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P Cmax data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Nab-P Tmax
The nab-P Tmax on Day -1 and Day 13 were observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P Tmax data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Median
Full Range
hr
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Nab-P Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration (AUClast)
The nab-P area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) on Day -1 and Day 13 were observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P AUClast data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.hr/mL
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Nab-P Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
The nab-P area under the plasma concentration-time curve from time 0 extrapolated to infinite time (AUCinf) on Day -1 and Day 13 observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P AUCinf data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.hr/mL
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
The nab-P t1/2 on Day -1 and Day 13 were observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P t1/2 data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Median
Full Range
hr
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Nab-P Clearance (CL)
The nab-P clearance on Day -1 and Day 13 were observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P clearance data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter per hour (L/hr)
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Secondary
Nab-P Volume of Distribution (Vz)
The nab-P on Day -1 and Day 13 were observed directly from data.
The analysis population included all enrolled participants treated who were treated. Number analyzed for each category represents the number of participants with Nab-P volume of distribution data for each time point. Results for groups with a small sample size could be misleading due to inter-individual variability and should be interpreted with caution.
Posted
Geometric Mean
Geometric Coefficient of Variation
L
Prior to nab-P infusion and at 30 min (end of infusion), 1, 2, 4, 6, 8, 24, and 48 hours post the start of paclitaxel infusion on Day -2 and 13 of Cycle 1.
ID
Title
Description
OG000
DL1 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
OG001
DL2A Palbociclib 100mg/Nab-Paclitaxel 100/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
Time Frame
From the signing of informed consent up to 56 days after the last administration of the investigational product, or 365 days from the first dose of investigational product, whichever is later.
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DL1 Palbociclib 75mg / Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m^2) weekly for 3 weeks out of each 28-day cycle.
0
3
2
3
3
3
EG001
DL2A Palbociclib 100mg / Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
1
7
4
7
7
7
EG002
DL2B Palbociclib 75mg / Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
3
4
3
4
4
4
EG003
DL3A Palbociclib 125mg / Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
2
11
4
11
11
11
EG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
3
11
6
11
10
11
EG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
5
11
9
11
11
11
EG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
2
9
2
9
9
9
EG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
6
20
12
20
20
20
EG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all patients from the MTD cohort.
7
27
15
27
27
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG0031 events1 affected11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
Myocardial infarction
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal obstrucion
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Disease progression
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Liver function test increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis bacterial
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Liver abscess
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Empyema
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Device occlusion
Product Issues
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events2 affected7 at risk
EG0023 events2 affected4 at risk
EG00311 events5 affected11 at risk
EG0046 events3 affected11 at risk
EG00511 events6 affected11 at risk
EG0061 events1 affected9 at risk
EG00717 events9 affected20 at risk
EG00822 events11 affected27 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG00110 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 events2 affected3 at risk
EG00137 events5 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0016 events3 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG00113 events6 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events2 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 events1 affected3 at risk
EG0012 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Asthenia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG00111 events3 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Catheter site irritation
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Early satiety
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 events2 affected3 at risk
EG00110 events4 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Deficiency of bile secretion
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ocular icterus
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Candida infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nail infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Perinephric abscess
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Septic shock
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Wound infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Activated partial thromboplastin time abnormal
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Liver function test increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0016 events2 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0016 events2 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 events2 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Ageusia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 events2 affected3 at risk
EG0013 events3 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Semnolence
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Confusion state
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Choluria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Micturition disorder
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0016 events6 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nail toxicity
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hot flush
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
The rationale for the study was supported on theoretical and preclinical grounds. However, based on emerging clinical data, the combination of palbociclib and nab-P was not to be further developed.
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.
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Title
Denominators
Categories
All causality treatment-emergent AEs
Title
Measurements
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Treatment-related treatment-emergent AEs
Title
Measurements
OG0003
OG0017
OG0024
OG003
All causality SAEs
Title
Measurements
OG0002
OG0014
OG0023
OG003
Treatment-related SAES
Title
Measurements
OG0000
OG0010
OG0021
OG003
All causality Grade 3 or 4 AEs
Title
Measurements
OG0003
OG0016
OG0023
OG003
Treatment-related Grade 3 or 4 AEs
Title
Measurements
OG0002
OG0015
OG0022
OG003
All causality Grade 5 AEs
Title
Measurements
OG0000
OG0011
OG0021
OG003
Treatment-related Grade 5 AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Title
Denominators
Categories
Anemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0017
OG0024
OG003
Hemoglobin increased
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Lymphocyte count increased
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Lymphopenia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Neutrophils (absolute)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Platelets
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
White blood cells
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Alanine aminotransferase (ALT)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Alkaline phosphatase
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Amylase
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Aspartate aminotransferase (AST)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Bilirubin (total)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Creatinine
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypercalcemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hyperglycemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hyperkalemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypermagnesemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypernatremia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypoalbuminemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypocalcemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypoglycemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypokalemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypomagnesemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hyponatremia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Hypophosphatemia
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
Liapase
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00311
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Title
Denominators
Categories
Maximum on-study SBP>150 or DBP>100
Title
Measurements
OG0001
OG0011
OG0020
OG0032
OG0042
OG0052
OG0061
OG0074
OG0085
Maximum on-study SBP >200 or DBP>110
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum increase from Baseline SBP>=20 and SBP<40
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum increase from Baseline SBP>=40 and SBP<60
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum increase from Baseline SBP>=60
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum increase from Baseline DBP>=10 and DPB<20
Title
Measurements
OG0000
OG0010
OG0021
OG003
Maximum increase from Baseline DBP>= 20 and DBP<30
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum increase from Baseline DBP >=30
Title
Measurements
OG0000
OG0011
OG0020
OG003
Maximum on-study pulse rate (bpm) >120
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum on-study pulse rate (bpm) <50
Title
Measurements
OG0000
OG0010
OG0020
OG003
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG0038
OG0049
OG0057
OG0066
OG00714
OG00821
Title
Denominators
Categories
Title
Measurements
OG0003
OG0015
OG0020
OG0037
OG0046
OG0055
OG0063
OG00710
OG00815
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG0038
OG0049
OG0057
OG0066
OG00714
OG00821
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0020
OG0035
OG0046
OG0054
OG0062
OG0075
OG00810
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG0038
OG0049
OG0057
OG0066
OG00714
OG00821
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0033
OG0044
OG0051
OG0061
OG0074
OG0088
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG0038
OG0049
OG0057
OG0066
OG00714
OG00821
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0082
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0047
OG0050
OG0060
OG00716
OG00823
Title
Denominators
Categories
Title
Measurements
OG00428.6(3.7 to 71.0)
OG0076.3(0.2 to 30.2)
OG00813.0(2.8 to 33.6)
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0047
OG0050
OG0060
OG00716
OG00823
Title
Denominators
Categories
Title
Measurements
OG004NA(3.8 to NA)Number of participants with CR/PR was too small.
OG0077.4(NA to NA)Number of participants with CR/PR was too small.
OG0087.4(3.8 to NA)Number of participants with CR/PR was too small.
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Title
Denominators
Categories
Title
Measurements
OG0009.1(3.7 to 9.1)
OG0019.5(1.8 to NA)Since not all participants had disease progression, the upper bound 95% CI cannot be estimated.
OG0021.7(1.4 to 1.9)
OG0033.5(1.7 to 7.2)
OG0045.5(0.8 to 14.5)
OG0055.3(1.6 to 6.9)
OG0061.8(1.5 to 8.6)
OG0073.8(2.4 to 9.7)
OG0085.3(3.5 to 9.7)
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Title
Denominators
Categories
Title
Measurements
OG00066.7(5.4 to 94.5)
OG00166.7(19.5 to 90.4)
OG002NA(NA to NA)Since not all participants had disease progression, 6m-PFSR and associated 95% CI cannot be estimated.
OG00330.0(7.1 to 57.8)
OG00436.4(11.2 to 62.7)
OG00527.3(6.5 to 53.9)
OG00625.0(3.7 to 55.8)
OG00736.2(13.4 to 59.9)
OG00836.5(17.0 to 56.3)
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00827
Title
Denominators
Categories
Title
Measurements
OG0009.8(8.8 to 16.3)
OG00123.4(5.6 to NA)Four (4) participants died and 3 were censored.
OG0023.3(2.1 to 7.7)
OG0037.2(4.0 to 15.3)
OG0049.9(0.8 to 14.8)
OG0055.3(2.4 to 11.7)
OG0067.2(4.0 to NA)Seven (7) participants died and 2 were censored.
OG00711.4(4.5 to 14.9)
OG00812.1(6.4 to 14.8)
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG00310
OG00410
OG00510
OG0069
OG00719
OG00826
Title
Denominators
Categories
p16(a)
Title
Measurements
OG0001
OG0012
OG0020
OG0035
OG0047
OG0056
OG0063
OG00710
OG00815
p16(b)
Title
Measurements
OG0001
OG0011
OG0020
OG003
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG00310
OG00410
OG00510
OG0069
OG00719
OG00826
Title
Denominators
Categories
Title
Measurements
OG00088.3± 7.64
OG00180.0± 29.79
OG00268.8± 23.23
OG00391.1± 10.24
OG00490.5± 18.77
OG00592.5± 8.25
OG00682.2± 32.70
OG00792.4± 19.10
OG00891.7± 19.54
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
MTD+DL3B
The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all participants from the MTD cohort.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG00310
OG00410
OG00510
OG0069
OG00719
OG00826
Title
Denominators
Categories
Title
Measurements
OG000158.3± 34.03
OG001154.0± 65.9
OG002108.8± 43.28
OG003166.7± 32.88
OG004176.0± 47.31
OG005172.5± 32.17
OG006145.6± 70.51
OG007187.9± 52.37
OG008185.4± 51.63
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts
OG008
Overall Participants With Dose Normalized to 125 mg/m^2
The overall participants with dose normalized to 125 mg/m^2
Units
Counts
Participants
OG0002
OG0016
OG0023
OG0036
OG0047
OG00510
OG0068
OG00715
OG00857
Title
Denominators
Categories
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG00190.68± 24
OG00257.30± 56
OG00398.79± 46
OG00464.55± 23
OG00548.05± 54
OG00653.65± 25
OG00770.14± 43
OG00890.44± 39
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0002
OG0016
OG0023
OG0036
OG0047
OG00510
OG0068
OG00715
OG00857
Title
Denominators
Categories
Title
Measurements
OG0004.93(4.20 to 5.65)
OG0015.00(4.00 to 7.92)
OG0023.90(3.00 to 24.0)
OG0035.83(4.05 to 25.0)
OG0044.50(3.88 to 6.25)
OG0055.00(1.83 to 7.17)
OG0066.01(0 to 8.00)
OG0074.17(0.600 to 7.98)
OG0085.05(0 to 25.0)
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0002
OG0016
OG0023
OG0036
OG0047
OG00510
OG0068
OG00715
OG00857
Title
Denominators
Categories
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG0011497± 18
OG002897.4± 36
OG0031867± 40
OG0041169± 21
OG005767.9± 42
OG006967.7± 26
OG0071251± 38
OG0081569± 34
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0002
OG0016
OG0023
OG0036
OG0046
OG00510
OG0068
OG00715
OG00856
Title
Denominators
Categories
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG00143.42± 34
OG00226.84± 19
OG00371.82± 42
OG00441.92± 11
OG00522.34± 37
OG00630.66± 34
OG00734.89± 34
OG00848.51± 38
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0002
OG0016
OG0023
OG0036
OG0047
OG00510
OG0068
OG00715
OG00857
Title
Denominators
Categories
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG00166.67± 18
OG00283.63± 36
OG00364.52± 40
OG00485.42± 21
OG00597.67± 42
OG00677.62± 26
OG00779.95± 38
OG00879.35± 34
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG00311
OG00411
OG00511
OG0068
OG00719
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0068
ParticipantsOG00719
ParticipantsOG00873
Title
Measurements
OG0001208± 250
OG0011595± 61
OG0021869± 47
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0037
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0068
ParticipantsOG00719
ParticipantsOG00873
Title
Measurements
OG0000.500(0.500 to 1.00)
OG0011.00(0.500 to 1.13)
OG0021.00(0.517 to 1.00)
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0037
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0068
ParticipantsOG00719
ParticipantsOG00873
Title
Measurements
OG0002071± 127
OG0013501± 48
OG0023489± 33
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0037
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG00410
ParticipantsOG0059
ParticipantsOG0067
ParticipantsOG00714
ParticipantsOG00862
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG0013851± 50
OG0023780± 30
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG00410
ParticipantsOG0059
ParticipantsOG0067
ParticipantsOG00714
ParticipantsOG00862
Title
Measurements
OG00016.95(16.6 to 17.3)
OG00111.10(7.75 to 18.6)
OG00212.00(10.9 to 16.6)
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG00410
ParticipantsOG0059
ParticipantsOG0067
ParticipantsOG00714
ParticipantsOG00862
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG00142.05± 56
OG00260.94± 36
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
OG002
DL2B Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG003
DL3A Palbociclib 125mg/Nab-Paclitaxel 100mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m2 weekly for 3 weeks out of each 28-day cycle.
OG004
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m^2 weekly for 3 weeks out of each 28-day cycle.
OG005
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2
This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m^2 biweekly in each 28-day cycle.
OG006
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2
This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m^2 biweekly in each 28-day cycle.
OG007
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2
The estimated maximum tolerated dose (MTD) was the DL associated with <33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts.
OG008
Overall Participants With Dose Normalized to 125 mg/m^2.
The overall participants with dose normalized to 125 mg/m^2.
Units
Counts
Participants
OG0003
OG0017
OG0024
OG00311
OG00411
OG00511
OG0069
OG00720
OG00876
Title
Denominators
Categories
Day -1
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG00410
ParticipantsOG0059
ParticipantsOG0067
ParticipantsOG00714
ParticipantsOG00862
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG001709.1± 44
OG0021140± 44
OG003
Day 13
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
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EG0081 events1 affected27 at risk
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0 affected
11 at risk
EG0040 events0 affected11 at risk
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0 affected
11 at risk
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0 events
0 affected
11 at risk
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EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
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EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
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11 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
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0 events
0 affected
11 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
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EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
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EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
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EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
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EG0060 events0 affected9 at risk
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EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0072 events1 affected20 at risk
EG0082 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0054 events4 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0072 events2 affected20 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
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EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
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EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0042 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0042 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
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EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
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0 affected
11 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
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0 events
0 affected
11 at risk
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EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
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EG0060 events0 affected9 at risk
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0 affected
11 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
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0 events
0 affected
11 at risk
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0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
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EG0070 events0 affected20 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
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EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
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EG0060 events0 affected9 at risk
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0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
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EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
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0 events
0 affected
11 at risk
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0 events
0 affected
11 at risk
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0 events
0 affected
11 at risk
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6 events
2 affected
11 at risk
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0 events
0 affected
11 at risk
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57 events
9 affected
11 at risk
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3 events
1 affected
11 at risk
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0 events
0 affected
11 at risk
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1 events
1 affected
11 at risk
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0 events
0 affected
11 at risk
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0 affected
11 at risk
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0 events
0 affected
11 at risk
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0 events
0 affected
11 at risk
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1 events
1 affected
11 at risk
EG0045 events2 affected11 at risk
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EG0065 events5 affected9 at risk
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0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
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1 events
1 affected
11 at risk
EG0040 events0 affected11 at risk
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EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
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0 events
0 affected
11 at risk
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3 events
2 affected
11 at risk
EG0042 events2 affected11 at risk
EG0054 events3 affected11 at risk
EG0061 events1 affected9 at risk
EG0078 events7 affected20 at risk
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0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0081 events1 affected27 at risk
5 events
2 affected
11 at risk
EG0046 events4 affected11 at risk
EG00511 events5 affected11 at risk
EG0063 events2 affected9 at risk
EG00717 events9 affected20 at risk
EG00822 events12 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0042 events1 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0073 events3 affected20 at risk
EG0083 events3 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected9 at risk
EG0071 events1 affected20 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
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EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0044 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
2 events
2 affected
11 at risk
EG0041 events1 affected11 at risk
EG0052 events2 affected11 at risk
EG0061 events1 affected9 at risk
EG0075 events5 affected20 at risk
EG0085 events5 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0072 events1 affected20 at risk
EG0082 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0052 events2 affected11 at risk
EG0061 events1 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0045 events2 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0084 events1 affected27 at risk
1 events
1 affected
11 at risk
EG0041 events1 affected11 at risk
EG0052 events1 affected11 at risk
EG0061 events1 affected9 at risk
EG0074 events2 affected20 at risk
EG0084 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected20 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected27 at risk
10
OG00411
OG00511
OG0069
OG00720
OG00827
4
OG0046
OG0059
OG0062
OG00712
OG00815
0
OG0042
OG0054
OG0061
OG0076
OG0086
9
OG00411
OG00510
OG0065
OG00720
OG00827
8
OG00411
OG0057
OG0064
OG00720
OG00827
1
OG0043
OG0055
OG0060
OG0071
OG0082
0
OG0041
OG0050
OG0060
OG0070
OG0080
11
OG00411
OG00511
OG0068
OG00720
OG00827
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0081
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0017
OG0022
OG0039
OG00410
OG00511
OG0067
OG00720
OG00827
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0017
OG0022
OG00310
OG00410
OG0059
OG0068
OG00720
OG00827
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0014
OG0020
OG0038
OG0048
OG0055
OG0061
OG00710
OG00815
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0017
OG0023
OG00310
OG00410
OG0059
OG0068
OG00720
OG00827
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0014
OG0021
OG0033
OG0044
OG0054
OG0065
OG00711
OG00815
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0016
OG0023
OG0039
OG0048
OG0058
OG0066
OG00715
OG00820
Participants
OG004
11
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG00719
ParticipantsOG00826
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0041
OG0050
OG0061
OG0071
OG0082
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0013
OG0021
OG0035
OG0046
OG0055
OG0066
OG0078
OG00813
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0040
OG0052
OG0060
OG0074
OG0084
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0017
OG0023
OG00310
OG00411
OG00510
OG0069
OG00718
OG00825
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0071
OG0082
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0017
OG0023
OG0039
OG0047
OG00510
OG0067
OG00716
OG00823
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0044
OG0052
OG0063
OG0076
OG0089
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
OG0082
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0062
OG0072
OG0082
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0012
OG0023
OG0035
OG0045
OG0057
OG0064
OG00710
OG00813
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0012
OG0022
OG0035
OG0045
OG0055
OG0065
OG0079
OG00812
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0043
OG0050
OG0060
OG0073
OG0086
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0002
OG0012
OG0020
OG0030
OG0041
OG0051
OG0060
OG0075
OG0086
Participants
OG004
11
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0001
OG0010
OG0022
OG0031
OG0043
OG0051
OG0060
OG0073
OG0086
Participants
OG004
11
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0003
OG0012
OG0023
OG0036
OG0043
OG0053
OG0062
OG0076
OG0088
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0000
OG0011
OG0021
OG0034
OG0040
OG0053
OG0062
OG0076
OG0086
Participants
OG004
11
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG00720
ParticipantsOG00827
Title
Measurements
OG0001
OG0011
OG0021
OG0032
OG0042
OG0052
OG0062
OG0075
OG0086
0
OG0040
OG0050
OG0060
OG0070
OG0080
5
OG0040
OG0052
OG0061
OG0074
OG0084
0
OG0043
OG0050
OG0060
OG0071
OG0083
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0045
OG0051
OG0064
OG0076
OG0089
0
OG0040
OG0050
OG0061
OG0071
OG0081
1
OG0041
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
4
OG0046
OG0054
OG0061
OG0079
OG00813
2733
± 127
OG0043396± 117
OG0053271± 113
OG0061851± 196
OG0073054± 129
OG0082827± 121
Participants
OG004
7
ParticipantsOG00510
ParticipantsOG0068
ParticipantsOG00715
ParticipantsOG00858
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG0011532± 146
OG0022316± 56
OG0031265± 219
OG0043073± 57
OG0052821± 93
OG0061266± 167
OG0073448± 73
OG0082487± 111
0.567
(0.483 to 1.00)
OG0040.600(0.483 to 1.00)
OG0050.500(0.450 to 1.03)
OG0060.775(0.500 to 1.00)
OG0070.500(0.000 to 1.17)
OG0080.517(0.000 to 1.17)
Participants
OG004
7
ParticipantsOG00510
ParticipantsOG0068
ParticipantsOG00715
ParticipantsOG00858
Title
Measurements
OG0000.592(0.583 to 0.600)
OG0010.583(0.500 to 1.20)
OG0020.500(0.500 to 1.00)
OG0031.00(0.500 to 1.05)
OG0040.517(0.467 to 1.00)
OG0050.500(0.450 to 1.17)
OG0060.575(0.500 to 1.03)
OG0070.533(0.467 to 1.50)
OG0080.542(0.450 to 1.50)
4291
± 70
OG0044895± 54
OG0054472± 59
OG0062632± 146
OG0073942± 60
OG0084211± 70
Participants
OG004
7
ParticipantsOG00510
ParticipantsOG0068
ParticipantsOG00715
ParticipantsOG00857
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG0012592± 70
OG0024096± 64
OG0032894± 133
OG0044095± 32
OG0054183± 44
OG0062071± 100
OG0074269± 52
OG0083812± 67
4157
± 48
OG0045387± 54
OG0055132± 56
OG0064116± 34
OG0074760± 49
OG0084977± 46
Participants
OG004
7
ParticipantsOG0059
ParticipantsOG0066
ParticipantsOG00713
ParticipantsOG00845
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG001NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG0024590± 60
OG0033349± 67
OG0044493± 29
OG0054482± 46
OG0062206± 118
OG0075135± 38
OG0084447± 55
15.25
(10.0 to 20.1)
OG00412.85(9.41 to 16.1)
OG00516.10(9.30 to 31.3)
OG00615.80(9.31 to 20.4)
OG00714.45(8.86 to 20.8)
OG00814.50(7.75 to 31.3)
Participants
OG004
7
ParticipantsOG0059
ParticipantsOG0066
ParticipantsOG00713
ParticipantsOG00845
Title
Measurements
OG00015.20(13.4 to 17.0)
OG00117.65(13.0 to 22.3)
OG00218.60(12.3 to 20.8)
OG00316.40(15.7 to 19.3)
OG00417.10(7.51 to 21.9)
OG00513.80(9.82 to 18.8)
OG00614.35(2.76 to 18.8)
OG00714.40(9.26 to 24.3)
OG00815.20(2.76 to 24.3)
41.69
± 51
OG00437.77± 46
OG00544.02± 51
OG00642.39± 34
OG00747.39± 48
OG00843.63± 46
Participants
OG004
7
ParticipantsOG0059
ParticipantsOG0066
ParticipantsOG00713
ParticipantsOG00845
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG001NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG00252.34± 65
OG00350.14± 78
OG00446.37± 33
OG00547.89± 48
OG00676.34± 131
OG00744.92± 40
OG00849.35± 57
891.3
± 37
OG004701.6± 46
OG005943.3± 56
OG006904.5± 39
OG007950.8± 51
OG008873.3± 46
Participants
OG004
7
ParticipantsOG0059
ParticipantsOG0066
ParticipantsOG00713
ParticipantsOG00845
Title
Measurements
OG000NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.
OG001NA± NAIt is Pfizer convention that the geometric mean value and CV% to be calculated from at least 3 data points, the number of participants was insufficient.