Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE v5.0
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer · Source last updated 2026-03-18
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 baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)
What was measured
Hematological parameters including neutrophil count decreased, white blood cell decreased, anemia, platelet count decreased, hemoglobin increased and leukocytosis were assessed. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment. As per NCI CTCAE v5.0, severity was graded as, Grade 1: mild, Grade 2: moderate, Grade 3: severe and Grade 4: life-threatening; urgent treatment indicated. Grade 0: Non-missing laboratory value that fell outside the grading range for the corresponding laboratory parameter. Categories with at least 1 non-zero values showing any shift in Grade from baseline to post-baseline were reported.
Analysis population: SAS included all randomized participants who receive at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Vepdegestrant (ARV-471)
Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
Fulvestrant
Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
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
Vepdegestrant (ARV-471)
310
Fulvestrant
303
Reported measurements
Neutrophil count decreased Grade 0 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
33
Not reported
Not reported
Not reported
Not reported
Fulvestrant
13
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 0 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
26
Not reported
Not reported
Not reported
Not reported
Fulvestrant
15
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 0 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
4
Not reported
Not reported
Not reported
Not reported
Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 0 to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 1 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
5
Not reported
Not reported
Not reported
Not reported
Fulvestrant
9
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 1 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
5
Not reported
Not reported
Not reported
Not reported
Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 1 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 2 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
2
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased Grade 3 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
0
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 0 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
68
Not reported
Not reported
Not reported
Not reported
Fulvestrant
31
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 0 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
18
Not reported
Not reported
Not reported
Not reported
Fulvestrant
8
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 0 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 1 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
10
Not reported
Not reported
Not reported
Not reported
Fulvestrant
12
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 1 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
10
Not reported
Not reported
Not reported
Not reported
Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 1 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
0
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 2 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
2
Not reported
Not reported
Not reported
Not reported
Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
White blood cell decreased Grade 2 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
0
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Anemia Grade 0 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
38
Not reported
Not reported
Not reported
Not reported
Fulvestrant
33
Not reported
Not reported
Not reported
Not reported
Anemia Grade 0 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
6
Not reported
Not reported
Not reported
Not reported
Fulvestrant
6
Not reported
Not reported
Not reported
Not reported
Anemia Grade 0 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Anemia Grade 1 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
14
Not reported
Not reported
Not reported
Not reported
Fulvestrant
12
Not reported
Not reported
Not reported
Not reported
Anemia Grade 1 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
17
Not reported
Not reported
Not reported
Not reported
Fulvestrant
11
Not reported
Not reported
Not reported
Not reported
Anemia Grade 1 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
4
Not reported
Not reported
Not reported
Not reported
Fulvestrant
4
Not reported
Not reported
Not reported
Not reported
Anemia Grade 2 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Anemia Grade 2 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
5
Not reported
Not reported
Not reported
Not reported
Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Anemia Grade 2 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
2
Not reported
Not reported
Not reported
Not reported
Fulvestrant
5
Not reported
Not reported
Not reported
Not reported
Platelet count decreased Grade 0 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
25
Not reported
Not reported
Not reported
Not reported
Fulvestrant
22
Not reported
Not reported
Not reported
Not reported
Platelet count decreased Grade 0 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
2
Not reported
Not reported
Not reported
Not reported
Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Platelet count decreased Grade 0 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
2
Not reported
Not reported
Not reported
Not reported
Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Platelet count decreased Grade 1 to Grade 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
3
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased Grade 1 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
0
Not reported
Not reported
Not reported
Not reported
Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased Grade 1 to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin increased Grade 0 to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
8
Not reported
Not reported
Not reported
Not reported
Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Hemoglobin increased Grade 0 to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Vepdegestrant (ARV-471)
1
Not reported
Not reported
Not reported
Not reported
Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
33
group Id
OG001
value
13
title
Neutrophil count decreased Grade 0 to Grade 1
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
15
title
Neutrophil count decreased Grade 0 to Grade 2
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
title
Neutrophil count decreased Grade 0 to Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Neutrophil count decreased Grade 0 to Grade 4
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
9
title
Neutrophil count decreased Grade 1 to Grade 0
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
3
title
Neutrophil count decreased Grade 1 to Grade 2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Neutrophil count decreased Grade 1 to Grade 3
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Neutrophil count decreased Grade 2 to Grade 0
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Neutrophil count decreased Grade 3 to Grade 2
categories
measurements
group Id
OG000
value
68
group Id
OG001
value
31
title
White blood cell decreased Grade 0 to Grade 1
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
8
title
White blood cell decreased Grade 0 to Grade 2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
White blood cell decreased Grade 0 to Grade 3
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
description
Hematological parameters including neutrophil count decreased, white blood cell decreased, anemia, platelet count decreased, hemoglobin increased and leukocytosis were assessed. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment. As per NCI CTCAE v5.0, severity was graded as, Grade 1: mild, Grade 2: moderate, Grade 3: severe and Grade 4: life-threatening; urgent treatment indicated. Grade 0: Non-missing laboratory value that fell outside the grading range for the corresponding laboratory parameter. Categories with at least 1 non-zero values showing any shift in Grade from baseline to post-baseline were reported.
groups
description
Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
id
OG000
title
Vepdegestrant (ARV-471)
description
Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
id
OG001
title
Fulvestrant
param Type
COUNT_OF_PARTICIPANTS
population Description
SAS included all randomized participants who receive at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)
title
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE v5.0
Triangle