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3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}],"units":"Participants"}],"title":"Hyponatremia Grade 3 to Grade 0"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}],"units":"Participants"}],"title":"Hyponatremia Grade 3 to Grade 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"310"},{"groupId":"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"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"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","unitOfMeasure":"Participants"}