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adverse reactions
6 ADVERSE REACTIONS The most common (incidence ≥10%) adverse reactions, including laboratory abnormalities were: hemoglobin decreased, musculoskeletal pain, calcium decreased, neutrophils decreased, AST increased, fatigue, diarrhea, ALT increased, triglycerides increased, nausea, platelets decreased, constipation, cholesterol increased, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of INLURIYO was evaluated in 651 patients with ER+, HER2- locally advanced or metastatic breast cancer previously treated with endocrine therapy with or without a prior CDK4/6 inhibitor in EMBER-3 [see Clinical Studies (14.1)] . Patients received INLURIYO 400 mg orally, once daily (n=327), or standard of care (n=324) consisting of either fulvestrant (n=292) or exemestane (n=32). Among patients who were treated with INLURIYO, the median duration of exposure was 5.6 months (range: 0.2 to 28.6 months) in EMBER-3. Serious adverse reactions occurred in 10% of patients who received INLURIYO. Serious adverse reactions in > 1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received INLURIYO, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%). Permanent treatment discontinuation of INLURIYO due to an adverse reaction occurred in 4.6% of patients. Adverse reactions which resulted in permanent discontinuation of INLURIYO included increased alanine aminotransferase (0.9%), abdominal pain, fatigue, fractured sacrum, hepatotoxicity, neuropathy peripheral, and pyrexia (each 0.3%). Dosage interruption of INLURIYO due to an adverse reaction occurred in 10% of patients. Adverse reactions which required dosage interruption in >0.5% were vomiting (1.5%); increased aspartate aminotransferase and COVID-19 (each 0.9%); and increased alanine aminotransferase, anemia, diarrhea, decreased neutrophil count, and pyrexia (each 0.6%). Dose reductions of INLURIYO due to an adverse reaction occurred in 2.4% of patients. Adverse reactions which required dose reductions were increased aspartate aminotransferase (0.6%); and increased alanine aminotransferase, anemia, fatigue, interstitial lung disease, nausea, neutropenia, and vomiting (each 0.3%). The most common (≥10%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, musculoskeletal pain, calcium decreased, neutrophils decreased, AST increased, fatigue, diarrhea, ALT increased, triglycerides increased, nausea, platelets decreased, constipation, cholesterol increased, and abdominal pain. Table 3 summarizes the adverse reactions in EMBER-3. Table 3: Adverse Reactions (≥10%) in Patients Who Received INLURIYO in EMBER-3 a Adverse reactions were graded using NCI CTCAE version 5.0. b Includes other related terms Adverse Reaction a INLURIYO N=327 Fulvestrant or Exemestane N=324 All Grades % Grades 3 or 4 % All Grades % Grades 3 or 4 % Musculoskeletal Disorders Musculoskeletal Pain 30 3.7 29 1.9 General Disorders and Administration Site Conditions Fatigue b 23 0.3 14 0.6 Gastrointestinal Disorders Diarrhea 22 0.6 12 0.0 Nausea 17 0.3 13 0.0 Constipation 10 0 6 0.3 Abdominal pain b 10 0.3 6 0.6 Clinically relevant adverse reactions (<10%) in patients who received INLURIYO included: vomiting (9%), headache (9%), cough (9%), decreased appetite (8%), hot flush (7%), pruritus (3.7%), dyspepsia (2.8%), and stomatitis (2.4%). Table 4 summarizes the laboratory abnormalities in EMBER-3. Table 4: Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received INLURIYO in EMBER-3 a Graded according to NCI CTCAE version 5 b The denominator used to calculate the rate varied from 252 to 325 based on the number of patients with a baseline value and at least one post-treatment value. Lab Abnormality a INLURIYO b Fulvestrant or Exemestane b All Grades % Grades 3 or 4 % All Grades % Grades 3 or 4 % Hematology Hemoglobin decreased 30 1.2 35 3.4 Neutrophils decreased 26 4 29 4.7 Platelets decreased 16 1.8 14 1.3 Chemistry Calcium decreased 26 0 19 0.6 Aspartate aminotransferase increased 25 1.9 27 2.3 Alanine aminotransferase increased 21 1.3 23 1.0 Triglycerides increased 21 0 22 1.2 Cholesterol increased 10 0 12 0