A Study Of PF-06647263 In Patients With Advanced Solid Tu... | NCT02078752 | Trialant
NCT02078752
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Apr 29, 2019Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Neoplasms
Triple-Negative Breast Cancer
Interventions
PF-06647263
PF-06647263
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02078752
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B7521001
Secondary IDs
Not provided
Brief Title
A Study Of PF-06647263 In Patients With Advanced Solid Tumors
Official Title
A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647263 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated due to a change in sponsor prioritization.
Expanded Access Info
No
Start Date
Apr 9, 2014Actual
Primary Completion Date
May 10, 2017Actual
Completion Date
May 10, 2017Actual
First Submitted Date
Mar 3, 2014
First Submission Date that Met QC Criteria
Mar 3, 2014
First Posted Date
Mar 5, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 7, 2018
Results First Submitted that Met QC Criteria
Jan 24, 2019
Results First Posted Date
Apr 29, 2019Actual
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
Jan 24, 2019
Last Update Posted Date
Apr 29, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description
The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the RP2D. Part 2 will include patients with previously treated metastatic triple negative breast cancer (TNBC).
Conditions Module
Conditions
Neoplasms
Triple-Negative Breast Cancer
Keywords
ADC
PF-06647263
solid tumors
tumors
neoplasm metastasis
TNBC
Triple negative breast cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1
Experimental
Drug: PF-06647263
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06647263
Drug
Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)
DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia (defined as neutropenia >=Grade 3 and a single body temperature >38.3°C or a sustained temperature of >=38°C for more than 1 hour); grade >=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia >=72 hours or platelets <=10,000/mm^3 regardless of duration. (2)Non- hematologic: bilirubin increase >=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.
Baseline up to Cycle 2 Day 1 (22 days)
Percentage of Participants With Objective Response (Part 2)
Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
Performance Status of 0 or 1
Adequate bone marrow, kidney, and liver function
Part 2 includes advanced triple negative breast cancer patients.
Exclusion Criteria:
Brain metastases requiring steroids
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
Active and clinically significant bacterial, fungal or viral infection
Garrido-Laguna I, Krop I, Burris HA 3rd, Hamilton E, Braiteh F, Weise AM, Abu-Khalaf M, Werner TL, Pirie-Shepherd S, Zopf CJ, Lakshminarayanan M, Holland JS, Baffa R, Hong DS. First-in-human, phase I study of PF-06647263, an anti-EFNA4 calicheamicin antibody-drug conjugate, in patients with advanced solid tumors. Int J Cancer. 2019 Oct 1;145(7):1798-1808. doi: 10.1002/ijc.32154. Epub 2019 Feb 23.
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
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
FG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG00113 subjects
FG0022 subjects
FG0037 subjects
FG0043 subjects
FG0059 subjects
FG0063 subjects
FG0076 subjects
FG0082 subjects
FG00912 subjects
COMPLETED
FG0001 subjects
FG0016 subjects
FG0021 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0017 subjects
FG0021 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Baseline analysis population included all participants who received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG001
PF-06647263 0.015 mg/kg QW (Part 1)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)
DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia (defined as neutropenia >=Grade 3 and a single body temperature >38.3°C or a sustained temperature of >=38°C for more than 1 hour); grade >=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia >=72 hours or platelets <=10,000/mm^3 regardless of duration. (2)Non- hematologic: bilirubin increase >=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.
The analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Count of Participants
Participants
Baseline up to Cycle 2 Day 1 (22 days)
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
The study was terminated due to sponsor's decision (for reasons other than safety) due to which data for few outcome measures was not analyzed and reported.
Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Part 1
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)
A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)
A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
Number of Participants With Vital Signs Abnormalities
Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP & DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP <90mmHg; (2) SBP change from baseline, maximum decrease >=30mmHg or maximum increase >=30mmHg; (3) minimum DBP <50mmHg; (4) DBP change from baseline, maximum decrease >=20mmHg or maximum increase >=20mmHg; (5) minimum supine pulse rate <40 BPM or maximum supine pulse rate >120 BPM.
Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)
Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263
AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.
Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263
Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Maximum Observed Serum Concentration (Cmax) of PF-06647263
Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Time for Cmax (Tmax) of PF-06647963
Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Clearance (CL) of PF-06647263
For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Volume of Distribution at Steady State (Vss) of PF-06647263
Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. In time frame, C=cycle, D=day.
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Terminal Serum Half-life (t1/2) of PF-06647263
T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. In time frame, C=cycle, D=day.
Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
AUC504 of Total Antibody
AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).
AUCtau of Total Antibody
Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Cmax of Total Antibody
Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Tmax of Total Antibody
Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
CL of Total Antibody
For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Vss of Total Antibody
Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
t1/2 of Total Antibody
T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
Cmax of Unconjugated Payload CL-184538
Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.
Baseline up to 7 days post end of treatment (Approximately 13 months)
Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538)
Positive was defined as: anti-drug antibody (ADA) titer >=1.88. In time frame, C=cycle, D=day.
QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody
Positive was defined as: neutralizing antibody titer >=1.30. In time frame, C=cycle, D=day.
QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody
Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.
QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
Percentage of Participants With Objective Response (Part 1)
Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Percentage of Participants With Clinical Benefit Response
Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm or appearance of >=1 new lesion), taking as reference the smallest sum diameters while on study.
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Progression Free Survival
The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Overall Survival (OS)-Stratifying for EFNA4 Expression (Part 2)
Baseline up to 24 months
Boston
Massachusetts
02115
United States
Dana-Farber Cancer Institute (DFCI)
Boston
Massachusetts
02215
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Comprehensive Cancer Centers Of Nevada
Las Vegas
Nevada
89169
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
Tennessee Oncology, PLLC
Nashville
Tennessee
37203
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Huntsman Cancer Hospital / University of Utah
Salt Lake City
Utah
84112
United States
Huntsman Cancer Institute-University of Utah
Salt Lake City
Utah
84112
United States
2 subjects
FG0055 subjects
FG0061 subjects
FG0073 subjects
FG0082 subjects
FG0092 subjects
1 subjects
FG0054 subjects
FG0062 subjects
FG0073 subjects
FG0080 subjects
FG00910 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0094 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0053 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
Other
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0095 subjects
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG008
PF-06647263 0.134 mg/kg QW (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
BG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
BG010
Total
Total of all reporting groups
3
BG00113
BG0022
BG0037
BG0043
BG0059
BG0063
BG0076
BG0082
BG00912
BG01060
Participants
Title
Denominators
Categories
Title
Measurements
18-44
BG0000
BG0012
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0091
BG0104
45-64
BG0002
BG0014
BG0022
BG0036
BG004
>=65
BG0001
BG0017
BG0020
BG0031
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG00112
BG0022
BG0037
BG0043
BG0057
BG0062
BG0074
BG0082
BG00912
BG01054
Male
BG0000
BG0011
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0002
BG00111
BG0021
BG0036
BG0043
BG0055
BG0062
BG0076
BG0082
BG00910
BG01048
Black
BG0001
BG0012
BG0021
BG0031
BG004
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Other
BG0000
BG0010
BG0020
BG0030
BG004
Unspecified
BG0000
BG0010
BG0020
BG0030
BG004
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG0037
OG0043
OG0059
OG0063
OG0076
OG0082
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0052
OG0060
OG0072
OG0082
Primary
Percentage of Participants With Objective Response (Part 2)
Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
The analysis set included all treated participants in Part 2 with measurable disease at baseline.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
ID
Title
Description
OG000
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG0008.3(0.2 to 38.5)
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Count of Participants
Participants
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG00113
OG0022
OG003
Secondary
Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)
An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Number
Participants
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG00111
OG0022
OG003
Secondary
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)
A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Number
Participants
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0016
OG0020
OG003
Secondary
Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)
A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Number
Participants
Baseline up to 28 days after the last treatment administration (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Secondary
Number of Participants With Vital Signs Abnormalities
Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP & DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP <90mmHg; (2) SBP change from baseline, maximum decrease >=30mmHg or maximum increase >=30mmHg; (3) minimum DBP <50mmHg; (4) DBP change from baseline, maximum decrease >=20mmHg or maximum increase >=20mmHg; (5) minimum supine pulse rate <40 BPM or maximum supine pulse rate >120 BPM.
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Count of Participants
Participants
Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Sitting systolic blood pressure (SBP) <90
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263
AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.
The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00110
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002299± 41
OG0012777± 26
OG0023958± 45
OG003
Secondary
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263
Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG00111
ParticipantsOG0022
ParticipantsOG003
Secondary
Maximum Observed Serum Concentration (Cmax) of PF-06647263
Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG00113
ParticipantsOG0022
ParticipantsOG003
Secondary
Time for Cmax (Tmax) of PF-06647963
Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Median
Full Range
hr
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG00113
ParticipantsOG0022
ParticipantsOG003
Secondary
Clearance (CL) of PF-06647263
For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG003
Secondary
Volume of Distribution at Steady State (Vss) of PF-06647263
Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG003
Secondary
Terminal Serum Half-life (t1/2) of PF-06647263
T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Mean
Standard Deviation
day
Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Units
Counts
Participants
OG0002
OG0013
OG0029
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG003
Secondary
AUC504 of Total Antibody
AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00111
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG00050080± 38
OG00164190± 26
OG00291730± 19
OG003
Secondary
AUCtau of Total Antibody
Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG00111
ParticipantsOG0022
ParticipantsOG003
Secondary
Cmax of Total Antibody
Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG00113
ParticipantsOG0022
ParticipantsOG003
Secondary
Tmax of Total Antibody
Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Median
Full Range
hr
QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG00113
ParticipantsOG0022
ParticipantsOG003
Secondary
CL of Total Antibody
For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG003
Secondary
Vss of Total Antibody
Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L
QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG003
Secondary
t1/2 of Total Antibody
T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.
Posted
Mean
Standard Deviation
day
Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.
ID
Title
Description
OG000
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Units
Counts
Participants
OG0002
OG0013
OG0029
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Cmax of Unconjugated Payload CL-184538
Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).
The analysis set was defined as enrolled patients who were analyzed for pharmacokinetics.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG001NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG002
Secondary
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.
The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.
Posted
Count of Participants
Participants
Baseline up to 7 days post end of treatment (Approximately 13 months)
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG00112
OG0022
OG003
Secondary
Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538)
Positive was defined as: anti-drug antibody (ADA) titer >=1.88. In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants tested for that parameter.
Posted
Count of Participants
Participants
QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Positive Anti-PF-06647263
ParticipantsOG0003
ParticipantsOG00113
ParticipantsOG0022
ParticipantsOG003
Secondary
Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody
Positive was defined as: neutralizing antibody titer >=1.30. In time frame, C=cycle, D=day.
The analysis set included all participants who were treated and tested for that parameter.
Posted
Count of Participants
Participants
QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0002
OG0015
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0033
OG004
Secondary
Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody
Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.
"Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants tested for that parameter.
Posted
Count of Participants
Participants
QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Treatment-emergent
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants With Objective Response (Part 1)
Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
The analysis set included treated participants with measurable disease at baseline.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Units
Counts
Participants
OG0002
OG00111
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 84.2)
OG0019.1(0.2 to 41.3)
OG0020(0.0 to 97.5)
OG003
Secondary
Percentage of Participants With Clinical Benefit Response
Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm or appearance of >=1 new lesion), taking as reference the smallest sum diameters while on study.
The analysis set included the number of participants with measurable disease at baseline.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0002
OG00111
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00050.0(1.3 to 98.7)
OG00136.4(10.9 to 69.2)
OG0020(0.0 to 97.5)
OG003
Secondary
Progression Free Survival
The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.
The analysis set included the number of participants with event.
Posted
Median
95% Confidence Interval
month
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
ID
Title
Description
OG000
PF-06647263 0.01 mg/kg QW (Part 1)
Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG008
PF-06647263 0.134 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
OG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0000
OG0018
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0013.0(1.4 to 7.1)
OG0031.4(0.6 to 8.3)
OG0045.3(1.9 to 5.3)
OG005
Secondary
Overall Survival (OS)-Stratifying for EFNA4 Expression (Part 2)
OS was not estimable since there were fewer number of participants with event.
Posted
Baseline up to 24 months
ID
Title
Description
OG000
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Units
Counts
Participants
OG0000
0
3
1
3
3
3
EG001
PF-06647263 0.015 mg/kg QW (Part 1)
Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
4
13
6
13
13
13
EG002
PF-06647263 0.015 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
0
2
0
2
2
2
EG003
PF-06647263 0.02 mg/kg QW (Part 1)
Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
0
7
0
7
7
7
EG004
PF-06647263 0.03 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
0
3
1
3
3
3
EG005
PF-06647263 0.05 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
1
9
1
9
9
9
EG006
PF-06647263 0.075 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
0
3
1
3
3
3
EG007
PF-06647263 0.1 mg/kg Q3W (Part 1)
Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
1
6
3
6
6
6
EG008
PF-06647263 0.134 mg/kg QW (Part 1)
Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
0
2
1
2
2
2
EG009
PF-06647263 0.015 mg/kg QW (Part 2)
Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
1
12
4
12
12
12
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gastric fistula
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Death
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Disease progression
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Pyrexia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Device related infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Sepsis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Paraesthesia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Influenza
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0042 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0072 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Splenic infarction
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Splenomegaly
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0014 affected13 at risk
EG0020 affected2 at risk
EG0033 affected7 at risk
EG0042 affected3 at risk
EG0053 affected9 at risk
EG0061 affected3 at risk
EG0073 affected6 at risk
EG0082 affected2 at risk
EG0093 affected12 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Palpitations
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dry eye
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Eye discharge
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Eye haemorrhage
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Eye irritation
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Eye pruritus
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Eye symptom
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Iritis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Lacrimation increased
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0042 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Mydriasis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Ocular hyperaemia
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Vision blurred
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vitreous floaters
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0073 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0042 affected3 at risk
EG0053 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0082 affected2 at risk
EG0090 affected12 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Abdominal rigidity
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Abdominal tenderness
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Aphthous ulcer
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Ascites
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0082 affected2 at risk
EG0090 affected12 at risk
Buccal mucosal roughening
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Constipation
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0015 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0053 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0093 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0034 affected7 at risk
EG0042 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0072 affected6 at risk
EG0081 affected2 at risk
EG0093 affected12 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0072 affected6 at risk
EG0081 affected2 at risk
EG0092 affected12 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gingival discolouration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Gingival disorder
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Haematemesis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0019 affected13 at risk
EG0022 affected2 at risk
EG0034 affected7 at risk
EG0043 affected3 at risk
EG0054 affected9 at risk
EG0063 affected3 at risk
EG0073 affected6 at risk
EG0082 affected2 at risk
EG0096 affected12 at risk
Oral disorder
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oral pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Proctitis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0021 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0053 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0091 affected12 at risk
Tongue coated
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Tongue discolouration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Tongue ulceration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0017 affected13 at risk
EG0021 affected2 at risk
EG0034 affected7 at risk
EG0041 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0072 affected6 at risk
EG0081 affected2 at risk
EG0096 affected12 at risk
Application site erosion
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Asthenia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0094 affected12 at risk
Catheter site erythema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Catheter site pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Catheter site related reaction
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Chest discomfort
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Chills
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0021 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Early satiety
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Face oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Fatigue
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG00110 affected13 at risk
EG0021 affected2 at risk
EG0035 affected7 at risk
EG0042 affected3 at risk
EG0056 affected9 at risk
EG0063 affected3 at risk
EG0074 affected6 at risk
EG0082 affected2 at risk
EG0095 affected12 at risk
Gait disturbance
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Generalised oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Malaise
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Mucosal inflammation
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0015 affected13 at risk
EG0020 affected2 at risk
EG0033 affected7 at risk
EG0041 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0072 affected6 at risk
EG0081 affected2 at risk
EG0097 affected12 at risk
Non-cardiac chest pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oedema peripheral
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0073 affected6 at risk
EG0081 affected2 at risk
EG0093 affected12 at risk
Pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0021 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Pyrexia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0042 affected3 at risk
EG0051 affected9 at risk
EG0062 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0092 affected12 at risk
Temperature intolerance
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hepatic congestion
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hepatic fibrosis
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hepatic steatosis
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Venoocclusive liver disease
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Seasonal allergy
Immune system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Angular cheilitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Asymptomatic bacteriuria
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Candida infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Clostridium difficile infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Conjunctivitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Device related infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Fungal infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Fungal skin infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Genital infection fungal
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Infected dermal cyst
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oral candidiasis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0062 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oral fungal infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pneumonia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Rash pustular
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rhinitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Vaginal infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Burns second degree
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0032 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Blood albumin decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Blood bilirubin increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Blood creatinine increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Breath sounds abnormal
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Cardiac murmur
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Electrocardiogram abnormal
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
International normalised ratio increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Neutrophil count decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Peritoneal fluid analysis
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Platelet count decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Transaminases increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Weight decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0052 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0091 affected12 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0016 affected13 at risk
EG0021 affected2 at risk
EG0034 affected7 at risk
EG0042 affected3 at risk
EG0054 affected9 at risk
EG0063 affected3 at risk
EG0074 affected6 at risk
EG0082 affected2 at risk
EG0095 affected12 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0041 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0091 affected12 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0062 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Marasmus
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0093 affected12 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Ageusia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Cognitive disorder
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Depressed level of consciousness
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Disturbance in attention
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dizziness
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0072 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Dizziness postural
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dysgeusia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0016 affected13 at risk
EG0020 affected2 at risk
EG0032 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0074 affected6 at risk
EG0082 affected2 at risk
EG0091 affected12 at risk
Encephalopathy
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Headache
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected13 at risk
EG0022 affected2 at risk
EG0032 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Memory impairment
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Neuralgia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Parosmia
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Presyncope
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Somnolence
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Tremor
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vocal cord paralysis
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Agitation
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Anxiety
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0042 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Confusional state
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Depression
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Insomnia
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Mental status changes
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Mood altered
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Bladder pain
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Chronic kidney disease
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dysuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Haematuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Proteinuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Urinary retention
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Pelvic fluid collection
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Perineal pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Vaginal discharge
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vulvovaginal inflammation
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Vulvovaginal rash
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected13 at risk
EG0021 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0015 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0062 affected3 at risk
EG0072 affected6 at risk
EG0081 affected2 at risk
EG0091 affected12 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0082 affected2 at risk
EG0091 affected12 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Laryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected13 at risk
EG0021 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0091 affected12 at risk
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0032 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0062 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0093 affected12 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Madarosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nail bed tenderness
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0072 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Papule
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0041 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0093 affected12 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected13 at risk
EG0021 affected2 at risk
EG0031 affected7 at risk
EG0041 affected3 at risk
EG0053 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Scar pain
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected13 at risk
EG0020 affected2 at risk
EG0032 affected7 at risk
EG0040 affected3 at risk
EG0052 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Skin fragility
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0081 affected2 at risk
EG0090 affected12 at risk
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0031 affected7 at risk
EG0041 affected3 at risk
EG0052 affected9 at risk
EG0061 affected3 at risk
EG0071 affected6 at risk
EG0082 affected2 at risk
EG0090 affected12 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Aortic stenosis
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Haemorrhage
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypertension
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0041 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypotension
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0013 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Pallor
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0090 affected12 at risk
Hypothyroidism
Endocrine disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Cataract
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Diplopia
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Axillary pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0092 affected12 at risk
Feeling abnormal
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Localised oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Bronchitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Nail infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Wound complication
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Weight increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Ketoacidosis
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Migraine
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Wound drainage
Surgical and medical procedures
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
Hot flush
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected13 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0040 affected3 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected2 at risk
EG0091 affected12 at risk
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.
D017437
Skin and Connective Tissue Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
3
BG0059
BG0061
BG0073
BG0080
BG0098
BG01038
0
BG0050
BG0062
BG0073
BG0081
BG0093
BG01018
0
BG0052
BG0061
BG0072
BG0080
BG0090
BG0106
0
BG0051
BG0060
BG0070
BG0080
BG0090
BG0106
0
BG0051
BG0060
BG0070
BG0080
BG0092
BG0103
0
BG0051
BG0061
BG0070
BG0080
BG0090
BG0102
0
BG0051
BG0060
BG0070
BG0080
BG0090
BG0101
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
OG0043
OG0059
OG0063
OG0075
OG0082
OG0098
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
OG0041
OG0051
OG0061
OG0073
OG0081
OG0094
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
OG0040
OG0050
OG0061
OG0070
OG0081
OG0091
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
OG0040
OG0051
OG0061
OG0071
OG0080
OG0091
Sitting diastolic blood pressure (DBP) <50
Title
Measurements
OG0001
OG0010
OG0020
OG0033
OG0040
OG0051
OG0061
OG0072
OG0080
OG0090
Sitting pulse rate <40
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Sitting pulse rate >120
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
OG0091
Max increase from baseline in sitting SBP >=30
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
OG0071
OG0080
OG0091
Max increase from baseline in sitting DBP >=20
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0041
OG0050
OG0060
OG0071
OG0080
OG0092
Max decrease from baseline in sitting SBP >=30
Title
Measurements
OG0001
OG0015
OG0022
OG0032
OG0041
OG0051
OG0062
OG0072
OG0081
OG0090
Max decrease from baseline in sitting DBP >=20
Title
Measurements
OG0001
OG0013
OG0021
OG0031
OG0040
OG0051
OG0062
OG0072
OG0081
OG0090
8
3414
± 23
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
6
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0082
ParticipantsOG00912
Title
Measurements
OG000594.1± 38
OG001544.8± 28
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were :458 and 1360
OG0031056± 31
OG0041246± 56
OG0053475± 36
OG0066023± 35
OG0076363± 18
OG008NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 8060 and 13400
OG009669.9± 31
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0098
Title
Measurements
OG000927.8± 33
OG0011166± 37
OG003NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 1370 and 1570
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 1800 and 1900.
OG0054617± 42
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 10200.
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
ParticipantsOG0043
ParticipantsOG0059
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG0082
ParticipantsOG00912
Title
Measurements
OG00012.64± 20
OG00111.96± 26
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 12.8 and 21.8.
OG00322.63± 24
OG00425.41± 60
OG00558.25± 40
OG00684.40± 38
OG007101.6± 34
OG008NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 131 and 154.
OG00916.86± 29
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0034
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG00912
Title
Measurements
OG00011.86± 33
OG00113.73± 47
OG00327.45± 48
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 21.2 and 18.1.
OG00541.98± 16
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 47.7 and 80.9.
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
ParticipantsOG0043
ParticipantsOG0059
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG0082
ParticipantsOG00912
Title
Measurements
OG0001.00(1.00 to 1.00)
OG0011.00(1.00 to 4.00)
OG0022.52(1.00 to 4.03)
OG0031.00(1.00 to 4.00)
OG0041.00(1.00 to 1.05)
OG0051.00(0.85 to 4.00)
OG0063.97(1.05 to 4.05)
OG0071.05(1.00 to 1.12)
OG0081.03(1.02 to 1.03)
OG0091.00(1.00 to 4.00)
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0034
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG00912
Title
Measurements
OG0001.00(1.00 to 1.00)
OG0011.00(1.00 to 1.00)
OG0031.00(1.00 to 1.00)
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0042.55(1.00 to 4.10)
OG0051.08(1.00 to 4.00)
OG0062.60(1.07 to 4.13)
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
ParticipantsOG0043
ParticipantsOG0057
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0082
ParticipantsOG0090
Title
Measurements
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.938.
OG0041.547± 33
OG0051.108± 24
OG0060.9244± 43
OG0070.9219± 39
OG008NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 1.06 and 0.807.
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0098
Title
Measurements
OG0000.7932± 15
OG0010.9454± 31
OG003NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 0.699 and 0.868.
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 0.944 and 1.47.
OG0050.6904± 36
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.441.
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
ParticipantsOG0043
ParticipantsOG0057
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0082
ParticipantsOG0090
Title
Measurements
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 116.
OG004162.7± 44
OG005114.8± 20
OG006134.0± 49
OG007116.5± 56
OG008NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value were 128 and 159.
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0097
Title
Measurements
OG00084.01± 28
OG001102.3± 49
OG003NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 96.1.
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 123 and 187.
OG005105.7± 18
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values. One of the individual values was 84.6. The other was not reported because CL value did not meet reporting criteria.
OG007
3
OG0046
OG0052
3
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG000NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values..
The individual value was 4.76.
OG0014.403± 0.593
OG0023.541± 0.756
OG0035.353± 0.542
OG0044.336± 1.02
OG005NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value were 5.16 and 5.28.
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
ParticipantsOG0042
ParticipantsOG0050
Title
Measurements
OG001NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 4.16 and 4.22.
OG0025.100± 1.56
OG003NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 4.93 and 5.79.
OG004
8
74250
± 40
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
6
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0082
ParticipantsOG00911
Title
Measurements
OG00012140± 29
OG00111780± 32
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 10500 and 38500.
OG00318900± 26
OG00438330± 63
OG00581710± 45
OG006173000± 39
OG007164400± 22
OG008NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 191000 and 419000.
OG00913950± 29
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0097
Title
Measurements
OG00021620± 30
OG00129740± 33
OG003NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 35100 and 35300.
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 61500 and 95900.
OG005155800± 62
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 398000.
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
ParticipantsOG0043
ParticipantsOG0058
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG0082
ParticipantsOG00911
Title
Measurements
OG000209.1± 23
OG001187.7± 23
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 240 and 424.
OG003357.2± 20
OG004482.9± 52
OG005865.9± 32
OG0061475± 45
OG0071622± 32
OG008NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 2120 and 2860.
OG009265.3± 27
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0034
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG00911
Title
Measurements
OG000229.6± 25
OG001282.7± 32
OG003506.5± 44
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 419 and 462.
OG005813± 32
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 1170 and 1830.
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
ParticipantsOG0043
ParticipantsOG0058
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG0082
ParticipantsOG00911
Title
Measurements
OG0001.00(1.00 to 4.00)
OG0011.00(1.00 to 4.00)
OG0021.00(1.00 to 1.00)
OG0031.00(1.00 to 4.00)
OG0041.00(1.00 to 1.05)
OG0051.00(0.850 to 4.00)
OG0061.05(1.05 to 4.05)
OG0071.08(1.00 to 4.00)
OG0083.81(3.62 to 4.00)
OG0091.00(1.00 to 4.00)
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0034
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG00911
Title
Measurements
OG0001.00(1.00 to 1.00)
OG0011.00(1.00 to 1.00)
OG0031.00(1.00 to 1.00)
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0042.55(1.00 to 4.10)
OG0051.08(1.00 to 4.00)
OG0062.60(1.07 to 4.13)
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.107.
OG0040.04455± 43
OG0050.04947± 17
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.0419.
OG0070.03471± 33
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0097
Title
Measurements
OG0000.03411± 5
OG0010.03736± 35
OG003NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 0.0312 and 0.0339.
OG009
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG004NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 0.0276 and 0.0292.
OG0050.02049± 45
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.0113.
OG007
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG002NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 6.30.
OG00410.32± 32
OG00510.96± 17
OG006NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 13.3.
OG0078.074± 51
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0092
Title
Measurements
OG000NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 4.82 and 5.19.
OG001NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 5.09 and 6.45.
OG009NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values..
Individual values were 3.87 and 4.06.
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG005NA± NAIndividual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 5.33.
3
OG0046
OG0052
1
ParticipantsOG0043
ParticipantsOG0050
Title
Measurements
OG000NA± NAFewer than 3 subjects had reportable parameter values. The individual value was 1.88.
OG0017.860± 0.581
OG0027.587± 2.34
OG003NA± NAFewer than 3 subjects had reportable parameter values. The individual value was 10.1.
OG0047.713± 1.52
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG002NA± NAFewer than 3 subjects had reportable parameter values. The individual value was 14.8.
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
NA
± NA
CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG003NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG004NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG005NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG006NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG007NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG008NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
OG009NA± NACL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00911
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
7
ParticipantsOG0043
ParticipantsOG0059
ParticipantsOG0063
ParticipantsOG0076
ParticipantsOG0082
ParticipantsOG00912
Title
Measurements
OG0002
OG0015
OG0020
OG0034
OG0042
OG0054
OG0061
OG0071
OG0080
OG0098
Positive Anti PF-06523432
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0098
Title
Measurements
OG0000
OG0013
OG0030
OG004
Positive Anti CL-184538
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0098
Title
Measurements
OG0002
OG0015
OG0032
OG004
4
OG0042
OG0054
OG0061
OG0071
OG0080
OG0098
2
OG0053
OG0061
OG0070
OG0098
7
OG0043
OG0059
OG0063
OG0076
OG0082
OG00912
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
Treatment-boosted
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
6
OG0043
OG0057
OG0063
OG0076
OG0082
16.7
(0.4 to 64.1)
OG0040(0.0 to 70.8)
OG00514.3(0.4 to 57.9)
OG00666.7(9.4 to 99.2)
OG0070(0.0 to 45.9)
OG0080(0.0 to 84.2)
6
OG0043
OG0057
OG0063
OG0076
OG0082
OG00912
16.7
(0.4 to 64.1)
OG00433.3(0.8 to 90.6)
OG00542.9(9.9 to 81.6)
OG00666.7(9.4 to 99.2)
OG00716.7(0.4 to 64.1)
OG0080(0.0 to 84.2)
OG00925.0(5.5 to 57.2)
4
OG0042
OG0054
OG0061
OG0072
OG0081
OG0098
5.8
(1.9 to 7.3)
OG006NA(1.4 to NA)With only one participant, we cannot calculate median or meaningful CI.
OG0072.8(0.6 to NA)Only 33.3% (2/6) of the participants were with event. A 95% CI for the quantile is the set of all efficacy endpoint variable values satisfying the formula. In this group, only one variable value satisfied, so upper limit was not estimable.
OG008NA(1.3 to NA)With only one participant, we cannot calculate median or meaningful CI.
OG0091.4(0.7 to 3.0)
1274
± 30
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 6820.
17.84
± 25
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 67.7 and 43.8.
1.00
(1.00 to 1.00)
1.56
(1.05 to 2.07)
0.8451
± 27
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.601.
72.31
± 21
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values. One of the individual values was 109. The other was not reported because CL value did not meet reporting criteria.
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 4.77 and 6.07.
32760
± 39
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 265000.
305
± 32
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
Individual values were 1080 and 1320.
1.00
(1.00 to 72.0)
2.55
(1.05 to 4.05)
0.03447
± 48
NA
± NA
Individual values are reported when fewer than 3 participants had report able parameter values.
The individual value was 0.0155.