Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors · Source last updated 2024-04-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure)
What was measured
Hematology abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported.
Analysis population: Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
Groups in this outcome
Part 1A PF-07263689 2*10^8 PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1A PF-07263689 6*10^8 PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Part 1A PF-07263689 20*10^8PFU
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 1A PF-07263689 2*10^8 PFU
3
Part 1A PF-07263689 6*10^8 PFU
4
Part 1A PF-07263689 20*10^8PFU
6
Reported measurements
Activated PTT prolonged: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
3
Not reported
Not reported
Not reported
Not reported
Activated PTT prolonged: Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
3
Not reported
Not reported
Not reported
Not reported
Activated PTT prolonged: Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
0
Not reported
Not reported
Not reported
Not reported
Anemia: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
0
Not reported
Not reported
Not reported
Not reported
Anemia: Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
4
Not reported
Not reported
Not reported
Not reported
Anemia: Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
1
Not reported
Not reported
Not reported
Not reported
Anemia: Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
1
Not reported
Not reported
Not reported
Not reported
Hemoglobin increased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
3
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
4
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
6
Not reported
Not reported
Not reported
Not reported
INR increased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
3
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
3
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
5
Not reported
Not reported
Not reported
Not reported
INR increased: Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
1
Not reported
Not reported
Not reported
Not reported
Leukocytosis: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
3
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
4
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
6
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased: Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
4
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
2
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased: Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
4
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
3
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
4
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
6
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
4
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
5
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased: Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
0
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased: Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
4
Not reported
Not reported
Not reported
Not reported
Platelet count decreased: Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
1
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
2
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
2
Not reported
Not reported
Not reported
Not reported
White blood cell decreased: Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
3
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
4
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
3
Not reported
Not reported
Not reported
Not reported
White blood cell decreased: Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
2
Not reported
Not reported
Not reported
Not reported
White blood cell decreased: Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1A PF-07263689 2*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 6*10^8 PFU
0
Not reported
Not reported
Not reported
Not reported
Part 1A PF-07263689 20*10^8PFU
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
3
title
Activated PTT prolonged: Grade 0
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
3
title
Activated PTT prolonged: Grade 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
Activated PTT prolonged: Grade 2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
title
Anemia: Grade 0
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
4
title
Anemia: Grade 1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
title
Anemia: Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
title
Anemia: Grade 3
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
6
title
Hemoglobin increased: Grade 0
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
5
title
INR increased: Grade 0
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
title
INR increased: Grade 1
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
6
title
Leukocytosis: Grade 0
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Lymphocyte count decreased: Grade 0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
6
units
Participants
description
Hematology abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported.
groups
description
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
id
OG000
title
Part 1A PF-07263689 2*10^8 PFU
description
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
id
OG001
title
Part 1A PF-07263689 6*10^8 PFU
description
Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
id
OG002
title
Part 1A PF-07263689 20*10^8PFU
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
reporting Status
POSTED
time Frame
From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure)
title
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade
Triangle