PF-06804103 Dose Escalation in HER2 Positive and Negative... | NCT03284723 | Trialant
NCT03284723
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Sep 3, 2024Actual
Enrollment
95Actual
Phase
Phase 1
Conditions
Breast Neoplasms
Interventions
PF-06804103
PF-06804103 + Palbociclib +Letrozole
Countries
United States
Australia
Italy
Russia
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT03284723
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C0541001
Secondary IDs
ID
Type
Description
Link
2017-002538-22
EudraCT Number
Brief Title
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
Official Title
A Phase 1 Dose Escalation Study Evaluating the Safety and Tolerability of PF-06804103 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive and Negative Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Aug 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The trial was terminated based on the stage in drug development and assessment of PF-06804103 relative to the leading external competition. The decision was not due to a safety concern.
Expanded Access Info
No
Start Date
Nov 1, 2017Actual
Primary Completion Date
Aug 31, 2021Actual
Completion Date
Aug 31, 2021Actual
First Submitted Date
Sep 1, 2017
First Submission Date that Met QC Criteria
Sep 13, 2017
First Posted Date
Sep 15, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jul 21, 2022
Results First Submitted that Met QC Criteria
Aug 27, 2024
Results First Posted Date
Sep 3, 2024Actual
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
Aug 27, 2024
Last Update Posted Date
Sep 3, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Neoplasms
Keywords
HER2
PF-06804103
ADC
breast cancer
neoplasms
solid tumors
human epidermal growth receptor 2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06804103
Experimental
Study Treatment
Drug: PF-06804103
PF-06804103+Combination Regimen
Experimental
Study Treatment
Drug: PF-06804103 + Palbociclib +Letrozole
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06804103
Drug
Dose Escalation Part - 1A Dose Expansion Part - 2A
PF-06804103
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Cycle 1 (21 Days) Dose-Limiting Toxicities (DLTs) in Part 1A
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose). (1) Hematologic: Grade 4 neutropenia lasting >7 days; febrile neutropenia; Grade >＝3 neutropenic infection; Grade >＝3 thrombocytopenia with bleeding; thrombocytopenia; (2) Non-hematologic: Grade >=3 toxicities that were considered clinically significant; delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting treatment related toxicities; concurrent AST or ALT >3x ULN and total bilirubin >2x ULN; any Grade 5 event.
First cycle, Day 1 up to Day 21
Number of Participants Wth Cycle 1 (28 Days) Dose-Limiting Toxicities (DLTs) in Part 1B
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 28 days of first dose). (1) Hematologic: including a delay greater than 1 week in administration of the next scheduled dose of study treatment due to persistent treatment-related toxicities; Grade 4 neutropenia lasting >7 days; febrile neutropenia; Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; thrombocytopenia. (2) Non-hematologic: including Grade >=3 toxicities that are considered clinically significant; Grade 3 QTc prolongation despite correction of reversible causes; delayed by >2 week in receiving the next scheduled dose of any study treatment due to persisting treatment-related toxicities; inability to administer at least 80% of the planned palbociclib or letrozole or 100% of the planned PF-06804103 doses during Cycle 1 due to toxicity related to the study treatment; concurrent AST or ALT >3x ULN and total bilirubin >2x ULN; any Grade 5 event.
First Cycle, Day 1 up to Day 28
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs), Treatment-Related TEAEs and SAEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs) were defined as those with initial onset or increasing in severity after the first dose of study medication. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response in Part 1
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
HER2 positive and negative breast cancer (Part 2A)
HER2 negative breast cancer (Part 1B & Part 2B)
Performance status of 0 or 1
Adequate bone marrow, kidney and liver function
Exclusion Criteria:
Known CNS disease including, but not limited to, metastases
History of exposure to certain cumulative doses of anthracyclines
Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
Active and clinically significant bacterial, fungal, or viral infection
Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Banner-University Medical Center Tucson
Tucson
Arizona
85719
United States
The University of Arizona Cancer Center - North Campus
Meric-Bernstam F, Calvo E, Lee KS, Moreno V, Park YH, Rha SY, Chalasani P, Zhong W, Zhou L, Pirie-Shepherd S, Leung ACF, Curigliano G. Safety and Tolerability of a Novel Anti-HER2 Antibody-Drug Conjugate (PF-06804103) in Patients with HER2-Expressing Solid Tumors: A Phase 1 Dose-Escalation Study. Mol Cancer Ther. 2023 Oct 2;22(10):1191-1203. doi: 10.1158/1535-7163.MCT-23-0101.
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
In Part 1A, 47 participants were treated at dose levels of PF-06804103 0.15, 0.5, 1.2, 2.0, 3.0, 4.0 and 5.0 mg/kg. In Part 2A, 46 participants were treated at dose levels of PF-06804103 3.0 and 4.0 mg/kg. In Part 1B, 2 participants received PF-06804103 2.0 mg/kg in combination with standard of care (SOC) doses of palbociclib and letrozole. Participants were unique in each part.
Recruitment Details
Part A (PF-06804103 monotherapy) included Part 1A (dose escalation part) and Part 2A (dose expansion part). Part B (PF-06804103 plus palbociclib and letrozole combination therapy) included Part 1B (dose escalation part).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
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
Prot
Yes
No
No
Study Protocol
Jan 24, 2020
Jul 19, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
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
PF-06804103 + Palbociclib +Letrozole
Drug
Dose Escalation - Part 1B Dose Expansion - Part 2B
PF-06804103+Combination Regimen
From the first dose of study treatment up to a minimum of 28 calendar days after the last dose of study treatment (maximum duration between first and last dose: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Number of Participants With Laboratory Abnormalities-Hematology
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated). This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: anemia, INR increased, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased.
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Number of Participants With Laboratory Abnormalities-Chemistries
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated). This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, hyperglycemia, hypermagnesemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase increased, serum amylase increased.
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Number of Participants With Laboratory Abnormalities-Urinalysis
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated). This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Number of Participants With Vital Signs Data Meeting Pre-Defined Criteria
Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in a supine or seated position.
From baseline up to follow up (at least 28 days and no more than 35 days after discontinuation of treatment), maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B
Percentage of Participants With Objective Response in Part 2
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
Duration of Response (DR) in Part 2
Duration of response (DR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
Progression-Free Survival (PFS) in Part 2
Progression-free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
Time to Tumor Progression (TTP) in Part 2
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death, or withdrawal from treatment (maximum treatment duration: 49.4 weeks)
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Duration of Response (DR) in Part 1
Duration of response (DR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Progression-Free Survival (PFS) in Part 1
Progression-free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Time to Tumor Progression (TTP) in Part 1
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06804103
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06804103.
Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Number of Participants With HER2 Positivity Based on Tumor Tissue Analysis
Tumor tissues from archived tissue biopsy were analyzed for HER2 mutations.
Baseline
Maximum Observed Concentration (Cmax) of PF-06804103 Antibody-Drug Conjugate (ADC)
Cmax is maximum observed serum concentration. Cmax for PF-06804103 ADC was observed directly from data. Part 2A used a sparse pharmacokinetic (PK) sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Terminal Serum Half-Life (t1/2) of PF-06804103 ADC
Terminal serum half-life (t1/2) is the time measured for the serum concentration of drug to decrease by one half. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Area Under The Serum Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06804103 ADC
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
Area Under the Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06804103 ADC
Tau refers to the dosing interval and it equals to 504 hours for Part 1A and 336 hours for Part 1B. AUCtau is the area under the concentration-time profile from time zero to time tau. AUCtau for PF-06804103 ADC was determined using linear/log trapezoidal method. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Clearance (CL) of PF-06804103 ADC
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06804103 ADC was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time zero extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Volume of Distribution at Steady State (Vss) of PF-06804103 ADC
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Observed Accumulation Ratio (Rac) of PF-06804103 ADC
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Rac=[Cycle 4 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1A, Rac=[Cycle 3 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1B. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
Cmax of PF-06804103 Total Antibody
Cmax is maximum observed serum concentration. Cmax for PF-06804103 total antibody was observed directly from data. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure. Total antibody means PF-06804103 with or without PF-06380101 conjugated. Both the antibody and small molecule components of the ADC are critical to its activity, requiring assays suited to measuring these disparate components. Each analyte provides unique information regarding ADC behavior in vivo and, singly or in combination, facilitates understanding of ADC PK.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
t1/2 of PF-06804103 Total Antibody
Terminal serum half-life (t1/2) is the time measured for the serum concentration of drug to decrease by one half. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
AUCinf of PF-06804103 Total Antibody
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
AUCtau of PF-06804103 Total Antibody
Tau refers to the dosing interval and it equals to 504 hours for Part 1A and 336 hours for Part 1B. AUCtau is the area under the concentration-time profile from time zero to time tau. AUCtau for PF-06804103 total antibody was determined using linear/log trapezoidal method. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
CL of PF-06804103 Total Antibody
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06804103 total antibody was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time zero extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Vss of PF-06804103 Total Antibody
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Rac of PF-06804103 Total Antibody
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Rac=[Cycle 4 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1A, Rac=[Cycle 3 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1B. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
Cmax of PF-06380101 Unconjugated Payload
Cmax is maximum observed serum concentration. Cmax for PF-06380101 unconjugated payload was observed directly from data. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure. Small molecule components (PF-06380101) of the ADC are critical to its activity, requiring assays suited to measuring these disparate components. Each analyte provides unique information regarding ADC behavior in vivo and, singly or in combination, facilitates understanding of ADC PK.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Time for Cmax (Tmax) of PF-06380101 Unconjugated Payload
Tmax is the time for Cmax. Tmax for PF-06380101 unconjugated payload was observed directly from data as time of first occurrence.Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
t1/2 of PF-06380101 Unconjugated Payload
Terminal serum half-life (t1/2) is the time measured for the serum concentration of drug to decrease by one half. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
AUCinf of PF-06380101 Unconjugated Payload
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
AUCtau of PF-06380101 Unconjugated Payload
Tau refers to the dosing interval and it equals to 504 hours for Part 1A and 336 hours for Part 1B. AUCtau is the area under the concentration-time profile from time zero to time tau. AUCtau for PF-06804103 total antibody was determined using linear/log trapezoidal method. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Rac of PF-06380101 Unconjugated Payload
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Rac=[Cycle 4 Day 1 AUCtau(dn) (multiple dose)]/[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1A, Rac=[Cycle 3 Day 1 AUCtau(dn) (multiple dose)]/[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1B. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
Tucson
Arizona
85719
United States
The University of Arizona Cancer Center
Tucson
Arizona
85724
United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles
California
90048
United States
UCLA Health (main campus)
Los Angeles
California
90095
United States
UCLA Hematology/Oncology
Los Angeles
California
90095
United States
Santa Monica - UCLA Medical Center and Orthopaedic Hospital
Santa Monica
California
90404
United States
UCLA Dept of Medicine - Hematology/Oncology, Santa Monica
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha
Nebraska
68130
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
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
Chris O'Brien Lifehouse
Camperdown
New South Wales
2050
Australia
Macquarie University
Macquarie Park
New South Wales
2109
Australia
Istituto Clinico Humanitas U. O. Oculistica
Milan
Lombardy
20089
Italy
Azienda Socio-Sanitaria Territoriale Monza
Monza
MB
20900
Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan
MI
20133
Italy
Divisione di Cardiologia - Istituto Europeo di Oncologia Divisione di Medicina Nucleare
Milan
MI
20141
Italy
Istituto Europeo di Oncologia
Milan
MI
20141
Italy
LLC "Clinica UZI 4D"
Pyatigorsk
Stavropol Kray
357502
Russia
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
Saint Petersburg
195271
Russia
National Cancer Center
Goyang-si
Gyeonggi-do
10408
South Korea
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
13620
South Korea
Gachon University Gil Medical Center
Incheon
21565
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón
Madrid
28223
Spain
Hospital Universitario Vall d'Hebron
Barcelona
08035
Spain
Hospital Clinic de Barcelona
Barcelona
08036
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid
28040
Spain
Hospital Universitario HM Sanchinarro
Madrid
28050
Spain
FG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
FG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
FG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
FG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
FG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
FG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
FG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
FG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
FG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
FG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
FG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG00416 subjects
FG00515 subjects
FG0066 subjects
FG0075 subjects
FG00814 subjects
FG00912 subjects
FG01015 subjects
FG0112 subjects
Received Treatment
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG00416 subjects
FG00515 subjects
FG0066 subjects
FG0075 subjects
FG00814 subjects
FG00912 subjects
FG01015 subjects
FG0112 subjects
COMPLETED
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG0049 subjects
FG00510 subjects
FG0063 subjects
FG0075 subjects
FG0086 subjects
FG0097 subjects
FG0109 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0047 subjects
FG0055 subjects
FG0063 subjects
FG0070 subjects
FG0088 subjects
FG0095 subjects
FG0106 subjects
FG0112 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0101 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated By Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline analysis population included all enrolled participants who received at least one dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
BG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
BG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
BG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
BG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
BG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
BG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
BG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
BG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
BG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
BG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
BG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0022
BG0034
BG00416
BG00515
BG0066
BG0075
BG00814
BG00912
BG01015
BG0112
BG01295
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00049.0± 19.8
BG00165.5± 0.71
BG00258.0± 11.31
BG003
Age, Customized
Number
Participants
Title
Denominators
Categories
<18
Title
Measurements
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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 Cycle 1 (21 Days) Dose-Limiting Toxicities (DLTs) in Part 1A
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose). (1) Hematologic: Grade 4 neutropenia lasting >7 days; febrile neutropenia; Grade >＝3 neutropenic infection; Grade >＝3 thrombocytopenia with bleeding; thrombocytopenia; (2) Non-hematologic: Grade >=3 toxicities that were considered clinically significant; delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting treatment related toxicities; concurrent AST or ALT >3x ULN and total bilirubin >2x ULN; any Grade 5 event.
Participants enrolled in Part 1A who received at least 1 dose of study treatment and who did not have major treatment deviations during first cycle.
Posted
Count of Participants
Participants
First cycle, Day 1 up to Day 21
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants Wth Cycle 1 (28 Days) Dose-Limiting Toxicities (DLTs) in Part 1B
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 28 days of first dose). (1) Hematologic: including a delay greater than 1 week in administration of the next scheduled dose of study treatment due to persistent treatment-related toxicities; Grade 4 neutropenia lasting >7 days; febrile neutropenia; Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; thrombocytopenia. (2) Non-hematologic: including Grade >=3 toxicities that are considered clinically significant; Grade 3 QTc prolongation despite correction of reversible causes; delayed by >2 week in receiving the next scheduled dose of any study treatment due to persisting treatment-related toxicities; inability to administer at least 80% of the planned palbociclib or letrozole or 100% of the planned PF-06804103 doses during Cycle 1 due to toxicity related to the study treatment; concurrent AST or ALT >3x ULN and total bilirubin >2x ULN; any Grade 5 event.
Participants enrolled in Part 1B who received at least 1 dose of study treatment and who did not have major treatment deviations during first cycle.
Posted
Count of Participants
Participants
First Cycle, Day 1 up to Day 28
ID
Title
Description
OG000
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Primary
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs), Treatment-Related TEAEs and SAEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs) were defined as those with initial onset or increasing in severity after the first dose of study medication. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
All enrolled participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
From the first dose of study treatment up to a minimum of 28 calendar days after the last dose of study treatment (maximum duration between first and last dose: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
Primary
Number of Participants With Laboratory Abnormalities-Hematology
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated). This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: anemia, INR increased, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased.
Participants who had at least one on-treatment assessment for the corresponding lab parameter.
Posted
Count of Participants
Participants
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Primary
Number of Participants With Laboratory Abnormalities-Chemistries
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated). This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, hyperglycemia, hypermagnesemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase increased, serum amylase increased.
Participants who had at least one on-treatment assessment for the corresponding lab parameter.
Posted
Count of Participants
Participants
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
Primary
Number of Participants With Laboratory Abnormalities-Urinalysis
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated). This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.
Participants who had at least one on-treatment assessment for the corresponding lab parameter.
Posted
Count of Participants
Participants
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Primary
Number of Participants With Vital Signs Data Meeting Pre-Defined Criteria
Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in a supine or seated position.
Participants who were evaluated against criteria.
Posted
Count of Participants
Participants
From baseline up to follow up (at least 28 days and no more than 35 days after discontinuation of treatment), maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Primary
Percentage of Participants With Objective Response in Part 2
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Participants received at least 1 dose of study treatment with adequate baseline assessment and at least 1 determinate post baseline assessment, disease progression, or death before the first tumor assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
ID
Title
Description
OG000
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG001
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Primary
Duration of Response (DR) in Part 2
Duration of response (DR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants received at least 1 dose of study treatment with adequate baseline assessment and at least 1 determinate post baseline assessment, disease progression, or death before the first tumor assessment. DR was only for the subset participants with an objective response.
Posted
Median
95% Confidence Interval
Month
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
ID
Title
Description
OG000
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
Primary
Progression-Free Survival (PFS) in Part 2
Progression-free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
All enrolled participants in part 2A.
Posted
Median
95% Confidence Interval
Month
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
ID
Title
Description
OG000
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG001
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG002
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Primary
Time to Tumor Progression (TTP) in Part 2
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
All enrolled participants in part 2A.
Posted
Median
95% Confidence Interval
Month
Baseline, every 6 weeks from the start of treatment until disease progression, death, or withdrawal from treatment (maximum treatment duration: 49.4 weeks)
ID
Title
Description
OG000
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG001
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG002
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Secondary
Percentage of Participants With Objective Response in Part 1
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Participants received at least 1 dose of study treatment with adequate baseline assessment and at least 1 determinate post baseline assessment, disease progression, or death before the first tumor assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF- 06804103 < 2.0 mg/kg
Participants with HER2-positive BC or HER-positive GC received PF-06804103 at 0.15 mg/kg or 0.5 mg/kg or 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06804103 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment for part 1A was approximately 89.3 weeks.
Secondary
Duration of Response (DR) in Part 1
Duration of response (DR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants received at least 1 dose of study treatment with adequate baseline assessment and at least 1 determinate post baseline assessment, disease progression, or death before the first tumor assessment. DR was only for the subset participants with an objective response.
Posted
Median
95% Confidence Interval
Month
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Progression-Free Survival (PFS) in Part 1
Progression-free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
All enrolled participants in part 1.
Posted
Median
95% Confidence Interval
Month
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 < 2.0 mg/kg
Participants with HER2-positive BC or HER-positive GC received PF-06804103 at 0.15 mg/kg or 0.5 mg/kg or 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06804103 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment for part 1A was approximately 89.3 weeks.
OG001
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Time to Tumor Progression (TTP) in Part 1
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
All enrolled participants in part 1.
Posted
Median
95% Confidence Interval
Month
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 < 2.0 mg/kg
Participants with HER2-positive BC or HER-positive GC received PF-06804103 at 0.15 mg/kg or 0.5 mg/kg or 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06804103 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment for part 1A was approximately 89.3 weeks.
OG001
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06804103
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06804103.
All enrolled participants who received at least one dose of study treatment and had at least 1 ADA sample collected.
Posted
Count of Participants
Participants
Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Secondary
Number of Participants With HER2 Positivity Based on Tumor Tissue Analysis
Tumor tissues from archived tissue biopsy were analyzed for HER2 mutations.
All enrolled participants with at least 1 of the biomarkers evaluated at pre- and/or post-dose.
Posted
Count of Participants
Participants
Baseline
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Maximum Observed Concentration (Cmax) of PF-06804103 Antibody-Drug Conjugate (ADC)
Cmax is maximum observed serum concentration. Cmax for PF-06804103 ADC was observed directly from data. Part 2A used a sparse pharmacokinetic (PK) sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram/milliliter (µg/mL)
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Terminal Serum Half-Life (t1/2) of PF-06804103 ADC
Terminal serum half-life (t1/2) is the time measured for the serum concentration of drug to decrease by one half. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
Day
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Area Under The Serum Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06804103 ADC
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour/milliliter (µg*hr/mL)
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Area Under the Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06804103 ADC
Tau refers to the dosing interval and it equals to 504 hours for Part 1A and 336 hours for Part 1B. AUCtau is the area under the concentration-time profile from time zero to time tau. AUCtau for PF-06804103 ADC was determined using linear/log trapezoidal method. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*hr/mL
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Clearance (CL) of PF-06804103 ADC
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06804103 ADC was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time zero extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour (L/hr)
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Secondary
Volume of Distribution at Steady State (Vss) of PF-06804103 ADC
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter (L)
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Observed Accumulation Ratio (Rac) of PF-06804103 ADC
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Rac=[Cycle 4 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1A, Rac=[Cycle 3 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1B. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Secondary
Cmax of PF-06804103 Total Antibody
Cmax is maximum observed serum concentration. Cmax for PF-06804103 total antibody was observed directly from data. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure. Total antibody means PF-06804103 with or without PF-06380101 conjugated. Both the antibody and small molecule components of the ADC are critical to its activity, requiring assays suited to measuring these disparate components. Each analyte provides unique information regarding ADC behavior in vivo and, singly or in combination, facilitates understanding of ADC PK.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Secondary
t1/2 of PF-06804103 Total Antibody
Terminal serum half-life (t1/2) is the time measured for the serum concentration of drug to decrease by one half. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
Day
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
Secondary
AUCinf of PF-06804103 Total Antibody
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*hr/mL
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
AUCtau of PF-06804103 Total Antibody
Tau refers to the dosing interval and it equals to 504 hours for Part 1A and 336 hours for Part 1B. AUCtau is the area under the concentration-time profile from time zero to time tau. AUCtau for PF-06804103 total antibody was determined using linear/log trapezoidal method. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*hr/mL
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
CL of PF-06804103 Total Antibody
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06804103 total antibody was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time zero extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Secondary
Vss of PF-06804103 Total Antibody
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
L
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Rac of PF-06804103 Total Antibody
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Rac=[Cycle 4 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1A, Rac=[Cycle 3 Day 1 AUCtau(dn) (multiple dose)] /[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1B. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Secondary
Cmax of PF-06380101 Unconjugated Payload
Cmax is maximum observed serum concentration. Cmax for PF-06380101 unconjugated payload was observed directly from data. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure. Small molecule components (PF-06380101) of the ADC are critical to its activity, requiring assays suited to measuring these disparate components. Each analyte provides unique information regarding ADC behavior in vivo and, singly or in combination, facilitates understanding of ADC PK.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram/milliliter (ng/mL)
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Secondary
Time for Cmax (Tmax) of PF-06380101 Unconjugated Payload
Tmax is the time for Cmax. Tmax for PF-06380101 unconjugated payload was observed directly from data as time of first occurrence.Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Median
Full Range
Hour
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
t1/2 of PF-06380101 Unconjugated Payload
Terminal serum half-life (t1/2) is the time measured for the serum concentration of drug to decrease by one half. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
Day
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
Secondary
AUCinf of PF-06380101 Unconjugated Payload
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour/milliliter (ng*hr/mL)
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
AUCtau of PF-06380101 Unconjugated Payload
Tau refers to the dosing interval and it equals to 504 hours for Part 1A and 336 hours for Part 1B. AUCtau is the area under the concentration-time profile from time zero to time tau. AUCtau for PF-06804103 total antibody was determined using linear/log trapezoidal method. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
Secondary
Rac of PF-06380101 Unconjugated Payload
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time zero to time tau (tau equals to 504 hours for Part 1A and 336 hours for Part 1B). Rac=[Cycle 4 Day 1 AUCtau(dn) (multiple dose)]/[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1A, Rac=[Cycle 3 Day 1 AUCtau(dn) (multiple dose)]/[Cycle 1 Day 1 AUCtau(dn) (single Dose)] for Part 1B. Part 2A used a sparse PK sampling schedule leaving very limited data for PK parameter estimation, so PK parameters from Part 2A were not reported. Only part 1A and part 1B treatment groups were included in this outcome measure.
Participants who received at least 1 dose of study treatment and had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
ID
Title
Description
OG000
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
OG001
PART 1A PF-06804103 0.5 mg/kg
Time Frame
Baseline up to 28 days after the last treatment administration, maximum duration between first and last dose: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B
Description
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an 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
PART 1A PF-06804103 0.15 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.15 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks. HER2 = Human Epidermal Growth Factor Receptor 2; BC = breast cancer; GC = gastric and gastroesophageal cancer.
1
2
1
2
2
2
EG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
0
2
0
2
2
2
EG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
0
2
0
2
2
2
EG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
1
4
1
4
4
4
EG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
0
16
7
16
16
16
EG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
1
15
5
15
15
15
EG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
1
6
4
6
6
6
EG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
0
5
2
5
5
5
EG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
0
14
6
14
14
14
EG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
3
12
5
12
11
12
EG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
1
15
7
15
15
15
EG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
0
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG0030 affected4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Asthenia
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Inflammation
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lipase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG0031 affected4 at risk
EG0047 affected16 at risk
EG0053 affected15 at risk
EG0062 affected6 at risk
EG0070 affected5 at risk
EG0084 affected14 at risk
EG0093 affected12 at risk
EG0102 affected15 at risk
EG0110 affected2 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blepharitis
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cataract
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Corneal disorder
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry eye
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye discharge
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye disorder
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye pain
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye swelling
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eyelid rash
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Keratitis
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Keratopathy
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Macular degeneration
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Photophobia
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Visual brightness
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gingival ulceration
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Asthenia
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site erythema
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site pain
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site swelling
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chest pain
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Face oedema
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0022 affected2 at risk
EG003
Gait disturbance
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Inflammation
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion site inflammation
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion site ulcer
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Injection site rash
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Injection site reaction
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mass
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oedema
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Pain
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blister infected
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cystitis escherichia
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ear infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pustule
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eyelid injury
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Incision site ulcer
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Amylase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Human epidermal growth factor receptor decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lipase increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lung diffusion test decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Platelet count increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Total lung capacity abnormal
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Weight decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
White blood cell count increased
Investigations
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperphosphatasaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tremor
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vocal cord paresis
Nervous system disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract disorder
Renal and urinary disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Genital discharge
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pelvic discomfort
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vulvovaginal inflammation
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bronchopleural fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pleural thickening
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Respiratory gas exchange disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nodular rash
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin lesion inflammation
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Systolic hypertension
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 24.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
On 10 February 2021, a decision was made by the sponsor to terminate the study due to business reasons. The decision was not due to any urgent patient safety concerns, study conduct issues, or regulatory authority requests concerning treatment with the PF-06804103 compound. Part 2B had not enrolled prior to the termination of the study.
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.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0075
OG00814
OG00912
OG01015
OG0112
Title
Denominators
Categories
Number of Participants with all-causality TEAEs
Title
Measurements
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0075
OG00814
OG00912
OG01015
OG0112
Number of Participants with all-causality SAEs
Title
Measurements
OG0001
OG0010
OG0020
OG003
Number of Participants with treatment-related TEAEs
Title
Measurements
OG0001
OG0011
OG0021
OG003
Number of Participants with treatment-related SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0075
OG00814
OG00912
OG01015
OG0112
Title
Denominators
Categories
Anemia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG003
INR increased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Lymphocyte count decreased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Neutrophil count decreased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
White blood cell decreased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0075
OG00814
OG00912
OG01015
OG0112
Title
Denominators
Categories
ALT increased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP increased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
AST increased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Hyperglycemia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Hypermagnesemia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Hypocalcemia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Hypokalemia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Hyponatremia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Hypophosphatemia
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Lipase increased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
Serum amylase increased
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00414
OG00515
OG0066
OG0074
OG0083
OG0096
OG0106
OG0110
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0075
OG00814
OG00912
OG01015
OG0112
Title
Denominators
Categories
Pulse rate >120 beats per minute (bpm)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
OG0061
OG0071
OG0083
OG0092
OG0101
OG0110
Increase in SBP ≥30 mmHg
Title
Measurements
OG0000
OG0010
OG0022
OG003
Decrease in SBP ≥30 mmHg
Title
Measurements
OG0000
OG0011
OG0020
OG003
Increase in DBP ≥20 mmHg
Title
Measurements
OG0000
OG0010
OG0022
OG003
Decrease in DBP ≥20 mmHg
Title
Measurements
OG0000
OG0011
OG0020
OG003
SBP value <90 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
DBP value <50 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG002
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG003
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
Units
Counts
Participants
OG0004
OG00111
OG00210
OG00311
Title
Denominators
Categories
Title
Measurements
OG00025.0(0.6 to 80.6)
OG00145.5(16.7 to 76.6)
OG00210.0(0.3 to 44.5)
OG00327.3(6.0 to 61.0)
OG001
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG002
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG003
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
Units
Counts
Participants
OG0001
OG0015
OG0021
OG0033
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Because there were few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0012.9(2.4 to NA)Because there were few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0024(NA to NA)Because there were few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG003NA(4.4 to NA)Because there were few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG003
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
Units
Counts
Participants
OG0005
OG00114
OG00212
OG00315
Title
Denominators
Categories
Title
Measurements
OG000NA(2.6 to NA)Because the number of participants in specific treatment groups is small and the PFS was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0015.5(2.9 to NA)Because the number of participants in specific treatment groups is small and the PFS was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0021.3(0.7 to 6.4)
OG0035.6(2.4 to NA)Because the number of participants in specific treatment groups is small and the PFS was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG003
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
Units
Counts
Participants
OG0005
OG00114
OG00212
OG00315
Title
Denominators
Categories
Title
Measurements
OG000NA(2.6 to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0015.5(2.9 to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0021.3(0.7 to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0035.6(2.4 to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG001
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0006
OG0014
OG00214
OG00314
OG0045
OG0051
Title
Denominators
Categories
Title
Measurements
OG00016.7(0.4 to 64.1)
OG0010(0.0 to 60.2)
OG00221.4(4.7 to 50.8)
OG00342.9(17.7 to 71.1)
OG00460.0(14.7 to 94.7)
OG005100.0(2.5 to 100.0)
OG001
PART 1A PF-06804103 0.5 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
OG0043
OG0056
OG0063
OG0071
Title
Denominators
Categories
Title
Measurements
OG0024.2(NA to NA)Because there were no or few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG00415.5(6 to 18.9)
OG0057.3(5.5 to 18.7)
OG006NA(NA to NA)Because there were no or few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG007NA(NA to NA)Because there were no or few confirmed responders for specific treatment groups and the duration of response was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG002
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0006
OG0014
OG00216
OG00315
OG0046
OG0052
Title
Denominators
Categories
Title
Measurements
OG0004.2(0.7 to 15.7)
OG0013.4(2.6 to NA)Because the number of participants in specific treatment groups is small and the PFS was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0024.7(1.2 to 7.2)
OG0038.2(4.3 to 14.9)
OG004NA(2.7 to NA)Because the number of participants in specific treatment groups is small and the PFS was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG005NA(NA to NA)Because the number of participants in specific treatment groups is small and the PFS was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG002
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0006
OG0014
OG00216
OG00315
OG0046
OG0052
Title
Denominators
Categories
Title
Measurements
OG0004.2(0.7 to 15.7)
OG0013.4(2.6 to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG0024.7(1.2 to 7.2)
OG0038.2(4.3 to 14.9)
OG004NA(2.7 to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
OG005NA(NA to NA)Because the number of participants in specific treatment groups is small and the TTP was censored for some participants, therefore there were insufficient number of participants with events, the estimation of median and 95% confidence intervals may not be feasible.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00412
OG00515
OG0066
OG0075
OG00813
OG00910
OG01015
OG0112
Title
Denominators
Categories
Participants with ADA
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG0052
OG0060
OG0070
OG0082
OG0094
OG0105
OG0110
Participants with NAb
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 2A PF-06804103 3.0 mg/kg HER2+ BC
Participants with HER2-positive BC in third line (3L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG008
PART 2A PF-06804103 4.0 mg/kg HER2+ BC
Participants with HER2-positive BC in 3L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG009
PART 2A PF-06804103 3.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in second line (2L) setting received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks. HR = hormone receptor; IHC = immunohistochemistry; ISH = in-situ hybridization.
OG010
PART 2A PF-06804103 4.0 mg/kg HR+ HER2-Low BC
Participants with HR-positive HER2 IHC
1+ or IHC 2+/ISH- BC in 2L setting received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 2A was approximately 49.4 weeks.
OG011
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00414
OG00515
OG0066
OG0075
OG00814
OG00912
OG01015
OG0112
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0021
OG0033
OG00410
OG00513
OG0066
OG0075
OG00814
OG0094
OG0101
OG0110
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0035120± 11
OG0049498± 32
OG00512940± 31
OG00616550± 38
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0047504± 28
OG00510730± 33
OG00611990± 23
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0043.037± 15
OG0053.106± 24
OG0063.467± 24
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0041.007± 20
OG0051.164± 22
OG0061.114± 15
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0036868± 62
OG00410770± 53
OG00515360± 58
OG00618010± 38
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034826± 18
OG0048231± 30
OG00510980± 32
OG00612870± 21
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0032.180± 9
OG0042.781± 12
OG0053.011± 23
OG0063.520± 20
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.7427± 73
OG0041.033± 18
OG0051.097± 15
OG0061.122± 19
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0072
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00416
OG00515
OG0066
OG0072
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003465.8± 45
OG004945.4± 51
OG0051256± 43
OG0061824± 83
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003478.0± 124
OG004556.5± 45
OG005780.8± 56
OG0061136± 19
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG002
PART 1A PF-06804103 1.2 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 1.2 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG003
PART 1A PF-06804103 2.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 2.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG004
PART 1A PF-06804103 3.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 3.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG005
PART 1A PF-06804103 4.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 4.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG006
PART 1A PF-06804103 5.0 mg/kg
Participants with HER2-positive BC or HER2-positive GC received PF-06804103 at 5.0 mg/kg on Day 1 of each 21-day cycle as an IV infusion. The maximum duration of treatment for Part 1A was approximately 89.3 weeks.
OG007
PART 1B PF-06804103 2.0 mg/kg HR+ HER2-Low Combo BC
Postmenopausal participants with HR-positive HER2 IHC 1+ or IHC 2+/ISH- BC received PF-06804103 at 2.0 mg/kg once every 14 days in a 28-day cycle as an IV infusion. The maximum duration of treatment for Part 1B was approximately 53.7 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0034
OG0049
OG00512
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0031.083± 64
OG0040.8088± 28
OG0050.9427± 49
OG0060.8507± 35
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
1 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0093 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0042 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0092 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0082 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
2 affected
4 at risk
EG0041 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0052 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0044 affected16 at risk
EG0052 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0102 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0102 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0083 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0052 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0052 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0084 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0072 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0092 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0043 affected16 at risk
EG0056 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0093 affected12 at risk
EG0102 affected15 at risk
EG0111 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
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4 at risk
EG0044 affected16 at risk
EG0055 affected15 at risk
EG0062 affected6 at risk
EG0072 affected5 at risk
EG0087 affected14 at risk
EG0094 affected12 at risk
EG0103 affected15 at risk
EG0112 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0042 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
1 affected
4 at risk
EG0042 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0081 affected14 at risk
EG0093 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0071 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0051 affected15 at risk
EG0061 affected6 at risk
EG0072 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0101 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0081 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
1 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0051 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0051 affected15 at risk
EG0061 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0091 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0040 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0071 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0043 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
0 affected
4 at risk
EG0041 affected16 at risk
EG0050 affected15 at risk
EG0060 affected6 at risk
EG0070 affected5 at risk
EG0080 affected14 at risk
EG0090 affected12 at risk
EG0100 affected15 at risk
EG0110 affected2 at risk
1
OG0047
OG0055
OG0064
OG0072
OG0086
OG0095
OG0107
OG0110
4
OG00415
OG00515
OG0066
OG0075
OG00814
OG00910
OG01015
OG0112
0
OG0043
OG0051
OG0062
OG0072
OG0085
OG0091
OG0105
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0091
OG0100
OG0110
Participants
OG004
14
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00812
ParticipantsOG00910
ParticipantsOG01013
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG00813
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0042
OG0051
OG0060
OG0070
OG0082
OG0092
OG0100
OG0110
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00813
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0083
OG0090
OG0100
OG0110
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0083
OG0090
OG0100
OG0111
0
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
OG0090
OG0101
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0052
OG0060
OG0070
OG0081
OG0090
OG0100
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00813
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00812
ParticipantsOG0099
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG0101
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00814
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
OG0062
OG0070
OG0083
OG0091
OG0100
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00813
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0092
OG0100
OG0110
Participants
OG004
16
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00812
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0061
OG0070
OG0082
OG0090
OG0100
OG0110
ParticipantsOG00416
ParticipantsOG00515
ParticipantsOG0066
ParticipantsOG0075
ParticipantsOG00813
ParticipantsOG00910
ParticipantsOG01015
ParticipantsOG0112
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0081
OG0090
OG0101
OG0110
2
OG0042
OG0059
OG0061
OG0071
OG0083
OG0093
OG0104
OG0111
2
OG0044
OG0055
OG0060
OG0073
OG0081
OG0091
OG0101
OG0110
2
OG0043
OG0057
OG0062
OG0072
OG0082
OG0094
OG0105
OG0111
1
OG0044
OG0056
OG0060
OG0072
OG0081
OG0091
OG0100
OG0110
0
OG0042
OG0056
OG0060
OG0071
OG0082
OG0090
OG0100
OG0110
1
OG0041
OG0053
OG0060
OG0071
OG0081
OG0091
OG0100
OG0110
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0102
OG0110
OG00336.97± 24
OG00471.24± 21
OG00578.91± 21
OG006103.1± 28
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00343.00± 15
OG00453.29± 29
OG00576.52± 24
OG00682.13± 7
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.495± 0.76081
OG0044.257± 1.1289
OG0055.001± 1.2963
OG0064.962± 1.3623
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0044.177± 1.1648
OG0055.185± 1.1855
OG0065.278± 2.2199
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.02073± 32
OG0040.01970± 27
OG0050.01884± 24
OG0060.01975± 40
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0040.02069± 28
OG0050.01731± 27
OG0060.01971± 49
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00346.77± 24
OG00478.17± 34
OG00589.67± 31
OG006117.7± 19
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00344.02± 10
OG00459.96± 26
OG00577.53± 21
OG00688.54± 9
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034.438± 2.3541
OG0044.775± 2.3152
OG0055.679± 2.4450
OG0064.530± 1.1946
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.520± 0.45133
OG0044.188± 1.1884
OG0055.159± 1.0528
OG0065.423± 3.3577
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.01544± 103
OG0040.01737± 47
OG0050.01587± 46
OG0060.01899± 37
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.01777± 15
OG0040.01890± 29
OG0050.01693± 27
OG0060.02023± 37
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0031.706± 73
OG0043.180± 41
OG0054.219± 43
OG0066.916± 67
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0032.254± 108
OG0042.185± 59
OG0053.094± 78
OG0064.790± 15
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003117(69.0 to 187)
OG00471.7(22.6 to 169)
OG005143(48.0 to 192)
OG00693.5(68.0 to 192)
OG007NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00370.1(43.9 to 73.3)
OG004140(47.9 to 167)
OG005105(46.1 to 166)
OG00684.0(69.0 to 96.0)
OG007NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034.170± 0.55923
OG0044.384± 1.1479
OG0055.164± 1.2816
OG0064.795± 1.3663
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Participants
OG004
9
ParticipantsOG00512
ParticipantsOG0064
ParticipantsOG0071
Title
Measurements
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034.723± 0.35275
OG0045.214± 1.0385
OG0055.889± 1.4216
OG006NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG007NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.