Skip to content

TriangleGet started

← Full study record

NCT05654623 · OUTCOME

Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities 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

Serum chemistry parameters including alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia 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 falls 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 received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for the specified rows.

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

Alanine aminotransferase increased Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	55	Not reported	Not reported	Not reported	Not reported
Fulvestrant	50	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	5	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	0	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	52	Not reported	Not reported	Not reported	Not reported
Fulvestrant	72	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	4	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	3	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	9	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Alkaline phosphatase increased Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	51	Not reported	Not reported	Not reported	Not reported
Fulvestrant	53	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	5	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	53	Not reported	Not reported	Not reported	Not reported
Fulvestrant	52	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	7	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	3	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Alkaline phosphatase increased Grade 2 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Aspartate aminotransferase increased Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	78	Not reported	Not reported	Not reported	Not reported
Fulvestrant	54	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	4	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Aspartate aminotransferase increased Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	76	Not reported	Not reported	Not reported	Not reported
Fulvestrant	84	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	5	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	4	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	2	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	3	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased Grade 3 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Blood bilirubin increased Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	30	Not reported	Not reported	Not reported	Not reported
Fulvestrant	12	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	9	Not reported	Not reported	Not reported	Not reported
Fulvestrant	7	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	3	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased Grade 0 to Grade 4

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	0	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	4	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Blood bilirubin increased Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Blood bilirubin increased Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Cholesterol high Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	273
Fulvestrant	263

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	22	Not reported	Not reported	Not reported	Not reported
Fulvestrant	31	Not reported	Not reported	Not reported	Not reported

Cholesterol high Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	273
Fulvestrant	263

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	23	Not reported	Not reported	Not reported	Not reported
Fulvestrant	20	Not reported	Not reported	Not reported	Not reported

Cholesterol high Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	273
Fulvestrant	263

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	6	Not reported	Not reported	Not reported	Not reported

Cholesterol high Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	273
Fulvestrant	263

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

Cholesterol high Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	273
Fulvestrant	263

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

Cholesterol high Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	273
Fulvestrant	263

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

Creatinine increased Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	22	Not reported	Not reported	Not reported	Not reported

Creatinine increased Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	9	Not reported	Not reported	Not reported	Not reported

Creatinine increased Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Creatinine increased Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	6	Not reported	Not reported	Not reported	Not reported

Creatinine increased Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	0	Not reported	Not reported	Not reported	Not reported

Creatinine increased Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Creatinine increased Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypercalcemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	24	Not reported	Not reported	Not reported	Not reported
Fulvestrant	21	Not reported	Not reported	Not reported	Not reported

Hypercalcemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	0	Not reported	Not reported	Not reported	Not reported

Hypercalcemia Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypercalcemia Grade 0 to Grade 4

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypercalcemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	3	Not reported	Not reported	Not reported	Not reported

Hypercalcemia Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypercalcemia Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypercalcemia Grade 1 to Grade 4

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hyperkalemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	21	Not reported	Not reported	Not reported	Not reported
Fulvestrant	24	Not reported	Not reported	Not reported	Not reported

Hyperkalemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	3	Not reported	Not reported	Not reported	Not reported

Hyperkalemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	5	Not reported	Not reported	Not reported	Not reported

Hyperkalemia Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypermagnesemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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	9	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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

Hypermagnesemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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

Hypermagnesemia Grade 3 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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

Hypernatremia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	11	Not reported	Not reported	Not reported	Not reported
Fulvestrant	4	Not reported	Not reported	Not reported	Not reported

Hypernatremia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypernatremia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypertriglyceridemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	41	Not reported	Not reported	Not reported	Not reported
Fulvestrant	36	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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

Hypertriglyceridemia Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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

Hypertriglyceridemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	19	Not reported	Not reported	Not reported	Not reported
Fulvestrant	11	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	9	Not reported	Not reported	Not reported	Not reported
Fulvestrant	5	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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	0	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridemia Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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

Hypertriglyceridemia Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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

Hypertriglyceridemia Grade 2 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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

Hypertriglyceridemia Grade 3 to Grade 4

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	272
Fulvestrant	258

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

Hypoalbuminemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	40	Not reported	Not reported	Not reported	Not reported
Fulvestrant	32	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	8	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	8	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	3	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypoalbuminemia Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypoalbuminemia Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypoalbuminemia Grade 2 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypocalcemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	20	Not reported	Not reported	Not reported	Not reported

Hypocalcemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	3	Not reported	Not reported	Not reported	Not reported

Hypocalcemia Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypocalcemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	5	Not reported	Not reported	Not reported	Not reported

Hypocalcemia Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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	1	Not reported	Not reported	Not reported	Not reported

Hypocalcemia Grade 2 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	302

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

Hypoglycemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	299
Fulvestrant	288

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	9	Not reported	Not reported	Not reported	Not reported

Hypoglycemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	299
Fulvestrant	288

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

Hypoglycemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	299
Fulvestrant	288

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

Hypokalemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	32	Not reported	Not reported	Not reported	Not reported
Fulvestrant	18	Not reported	Not reported	Not reported	Not reported

Hypokalemia Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypokalemia Grade 2 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypokalemia Grade 2 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia Grade 3 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hypomagnesemia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	19	Not reported	Not reported	Not reported	Not reported
Fulvestrant	12	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia Grade 0 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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

Hypomagnesemia Grade 1 to Grade 2

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia Grade 2 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	298

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

Hyponatremia Grade 0 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	34	Not reported	Not reported	Not reported	Not reported
Fulvestrant	32	Not reported	Not reported	Not reported	Not reported

Hyponatremia Grade 0 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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	2	Not reported	Not reported	Not reported	Not reported

Hyponatremia Grade 1 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	303

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	7	Not reported	Not reported	Not reported	Not reported
Fulvestrant	8	Not reported	Not reported	Not reported	Not reported

Hyponatremia Grade 1 to Grade 3

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	303

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

Hyponatremia Grade 3 to Grade 0

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Hyponatremia Grade 3 to Grade 1

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	310
Fulvestrant	303

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

Complete source fields

classes

categories
measurements
group Id
OG000
value
55
group Id
OG001
value
50
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 0 to Grade 1
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 0 to Grade 2
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 0 to Grade 3
categories
measurements
group Id
OG000
value
52
group Id
OG001
value
72
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 1 to Grade 0
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 1 to Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 1 to Grade 3
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
9
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 2 to Grade 0
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants
title
Alanine aminotransferase increased Grade 2 to Grade 1
categories
measurements
group Id
OG000
value
51
group Id
OG001
value
53
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
302
units
Participants
title
Alkaline phosphatase increased Grade 0 to Grade 1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
302
units
Participants
title
Alkaline phosphatase increased Grade 0 to Grade 2
categories
measurements
group Id
OG000
value
53
group Id
OG001
value
52
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
302
units
Participants
title
Alkaline phosphatase increased Grade 1 to Grade 0
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
7
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
302
units
Participants
title
Alkaline phosphatase increased Grade 1 to Grade 2

denoms

counts
group Id
OG000
value
310
group Id
OG001
value
303
units
Participants

description

Serum chemistry parameters including alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia 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 falls 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 received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for the specified rows.

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 Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE v5.0

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice