Home FDA labels 29f2a48e-b9af-486e-bc0c-eab3a1ce0b3c CLIGAVYX openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name CLIGAVYX
Generic name FULVESTRANT
Manufacturer Avyxa Pharma, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID e20d8ca3-8837-4003-8b01-1ebec342062a
SPL ID 29f2a48e-b9af-486e-bc0c-eab3a1ce0b3c
Version 6
Effective date 2026-06-24
Source export date 2026-10-12
Source partition 3
Source file https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Risk of Bleeding: Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. ( 5.1 ) Injection Site Reaction: Use caution while administering CLIGAVYX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve. ( 5.2 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) Immunoassay Measurement of Serum Estradiol: CLIGAVYX can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels. ( 5.4 ) 5.1 Risk of Bleeding Because CLIGAVYX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. 5.2 Injection Site Reaction Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant. Caution should be taken while administering CLIGAVYX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve [see Dosage and Administration (2.3) and Adverse Reactions (6.1) ] . 5.3 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, fulvestrant can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CLIGAVYX and for one year after the last dose [see Use in Specific Populations (8.1) , (8.3) and Clinical Pharmacology (12.1) ] . 5.4 Immunoassay Measurement of Serum Estradiol Due to structural similarity of fulvestrant and estradiol, fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.
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adverse reactions table <table ID="ID56" width="578" styleCode="Noautorules"><caption> Table 4: Adverse Reactions in Studies 0020 and 0021 (≥5% from Combined Data) </caption><col width="253"/><col width="181"/><col width="144"/><tfoot><tr><td align="left" colspan="3"><paragraph styleCode="Footnote"><sup>1.</sup> Including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy. All patients on fulvestrant received injections, but only those anastrozole patients who were in Study 0021 received placebo injections.</paragraph></td></tr></tfoot><tbody><tr><td valign="top" styleCode="Lrule Toprule Botrule Rrule" align="left"><content styleCode="bold"> Adverse Reactions</content> </td><td valign="top" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Fulvestrant 250 mg</content> <content styleCode="bold"> N=423</content> <content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Anastrozole 1 mg</content> <content styleCode="bold"> N=423</content> <content styleCode="bold"> %</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Body as a Whole</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 68 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 68 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Asthenia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 23 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 27 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 20 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Headache </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 17 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Back Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 14 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Abdominal Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Injection Site Pain<content styleCode="italics"><sup>1</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pelvic Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Chest Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Flu Syndrome </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Fever </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Accidental Injury </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Cardiovascular System</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 30 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 28 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Vasodilatation </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 17 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Digestive System</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 52 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 48 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 26 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 25 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Constipation </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Anorexia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Hemic and Lymphatic Systems</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 14 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 14 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Metabolic and Nutritional Disorders</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Peripheral Edema </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Musculoskeletal System</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 26 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 28 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Bone Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 16 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 14 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Arthritis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Nervous System</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dizziness </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Insomnia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Paresthesia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Depression </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Anxiety </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Respiratory System</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 39 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pharyngitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 16 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dyspnea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Cough Increased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Skin and Appendages</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 22 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 23 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Rash </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Sweating </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Urogenital System</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Urinary Tract Infection </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td></tr></tbody></table>
adverse reactions table <table ID="ID58" width="633" styleCode="Noautorules"><caption> Table 5: Adverse Reactions (≥10%)in PALOMA-3 </caption><col width="177"/><col width="78"/><col width="75"/><col width="77"/><col width="84"/><col width="67"/><col width="75"/><tbody><tr><td valign="top" styleCode="Lrule Toprule Rrule" align="left"> </td><td colspan="3" valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Fulvestrant plus Palbociclib</content> </td><td colspan="3" valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Fulvestrant plus Placebo</content> </td></tr><tr><td valign="top" styleCode=" Lrule Rrule" align="left"> </td><td colspan="3" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> N=345</content> </td><td colspan="3" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> N=172</content> </td></tr><tr><td valign="top" styleCode=" Lrule Rrule" align="left"><content styleCode="bold"> Adverse Reactions</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> All Grades</content> </td><td valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Grade 3</content> </td><td valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Grade 4</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> All Grades</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> Grade 3</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> Grade 4</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Infections and Infestations</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Infections<content styleCode="italics"><sup>1</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 47<content styleCode="italics"><sup>2</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 31 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Blood and Lymphatic System Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Neutropenia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 83 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 55 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Leukopenia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 53 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 30 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 30 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Thrombocytopenia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 23 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Metabolism and Nutrition Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Decreased appetite </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 16 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Gastrointestinal Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 28 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Stomatitis<content styleCode="italics"><sup>3</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 28 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 24 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Skin and Subcutaneous Tissue Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Alopecia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18<content styleCode="italics"><sup>4</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> N/A </td><td valign="top" styleCode=" Botrule Rrule" align="center"> N/A </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6<content styleCode="italics"><sup>5</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> N/A </td><td valign="top" styleCode=" Botrule Rrule" align="center"> N/A </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Rash<content styleCode="italics"><sup>6</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 17 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> General Disorders and Administration Site Conditions</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 41 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 29 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pyrexia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" align="left"> Grading according to CTCAE v.4.0. </td></tr><tr><td colspan="7" valign="top" align="left"> CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>1.</sup> Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>2.</sup> Most common infections (≥1%) include: nasopharyngitis, upper respiratory infection, urinary tract infection, influenza, bronchitis, rhinitis, conjunctivitis, pneumonia, sinusitis, cystitis, oral herpes, respiratory tract infection, gastroenteritis, tooth infection, pharyngitis, eye infection, herpes simplex, paronychia. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>3.</sup> Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, stomatitis. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>4. </sup>Grade 1 events – 17%; Grade 2 events – 1%. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>5. </sup>Grade 1 events – 6%. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>6. </sup>Rash includes: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, toxic skin eruption. </td></tr></tbody></table>
adverse reactions table <table ID="ID60" width="639" styleCode="Noautorules"><caption> Table 6: Laboratory Abnormalities in PALOMA-3 </caption><col width="178"/><col width="88"/><col width="75"/><col width="68"/><col width="82"/><col width="71"/><col width="77"/><tfoot><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">N=number of patients; WBC=white blood cells.</paragraph></td></tr></tfoot><tbody><tr><td valign="top" styleCode="Lrule Toprule Rrule"/><td colspan="3" valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Fulvestrant plus Palbociclib</content> </td><td colspan="3" valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Fulvestrant plus Placebo</content> </td></tr><tr><td valign="top" styleCode=" Lrule Rrule"/><td colspan="3" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> N=345</content> </td><td colspan="3" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> N=172</content> </td></tr><tr><td valign="top" styleCode=" Lrule Rrule" align="left"><content styleCode="bold"> Laboratory Parameters</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> All Grades</content> </td><td valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Grade 3</content> </td><td valign="top" styleCode=" Toprule Rrule" align="center"><content styleCode="bold"> Grade 4</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> All Grades</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> Grade 3</content> </td><td valign="top" styleCode=" Rrule" align="center"><content styleCode="bold"> Grade 4</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> %</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> WBC decreased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 99 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 45 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 26 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Neutrophils decreased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 96 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 56 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 14 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Anemia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 78 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 40 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Platelets decreased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 62 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Aspartate aminotransferase increased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 43 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 48 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Alanine aminotransferase increased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 36 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr></tbody></table>
adverse reactions table <table ID="ID62" width="672" styleCode="Noautorules"><caption> Table 7: Adverse Reactions ≥10% of Patients Receiving Fulvestrant Plus Abemaciclib and ≥2% Higher Than Fulvestrant Plus Placebo in MONARCH 2 </caption><col width="272"/><col width="76"/><col width="62"/><col width="62"/><col width="76"/><col width="62"/><col width="62"/><tbody><tr><td styleCode="Lrule Toprule Botrule Rrule" align="center"><content styleCode="bold"> Adverse Reactions</content> </td><td colspan="3" valign="top" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Fulvestrant plus </content> <content styleCode="bold"> Abemaciclib </content> <content styleCode="bold"> N=441</content> </td><td colspan="3" valign="top" styleCode=" Toprule Botrule Rrule" align="center"><content styleCode="bold"> Fulvestrant plus Placebo</content> <content styleCode="bold"> N=223</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All</content> <content styleCode="bold"> Grades</content> <content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade</content> <content styleCode="bold"> 3</content> <content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade</content> <content styleCode="bold"> 4</content> <content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> All</content> <content styleCode="bold"> Grades</content> <content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade</content> <content styleCode="bold"> 3</content> <content styleCode="bold"> %</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Grade</content> <content styleCode="bold"> 4</content> <content styleCode="bold"> %</content> </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Gastrointestinal Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 86 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 25 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 45 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 23 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Abdominal pain<content styleCode="italics"><sup>1</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 35 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 16 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 26 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Stomatitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Infections and Infestations</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Infections<content styleCode="italics"><sup>2</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 43 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 25 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Blood and Lymphatic System Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Neutropenia<content styleCode="italics"><sup>3</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 46 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 24 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Anemia<content styleCode="italics"><sup>4</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 29 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Leukopenia<content styleCode="italics"><sup>5</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 28 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Thrombocytopenia<content styleCode="italics"><sup>6</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 16 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> General Disorders and Administration Site Conditions</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Fatigue<content styleCode="italics"><sup>7</sup></content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 46 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 32 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Edema peripheral </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pyrexia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Metabolism and Nutrition Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Decreased appetite </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 27 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Respiratory, Thoracic, and Mediastinal Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Cough </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Skin and Subcutaneous Tissue Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Alopecia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 16 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pruritus </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Rash </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Nervous System Disorders</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Headache </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 20 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dysgeusia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dizziness </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode=" Lrule Botrule" align="left"><content styleCode="bold"> Investigations</content> </td><td valign="top" styleCode=" Botrule"/><td valign="top" styleCode=" Botrule"/><td valign="top" styleCode=" Botrule"/><td valign="top" styleCode=" Botrule"/><td valign="top" styleCode=" Botrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Alanine aminotransferase increased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Aspartate aminotransferase increased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Creatinine increased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Weight decreased </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 2 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> <1 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 0 </td></tr><tr><td colspan="7" valign="top" align="left"><sup>1.</sup> Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, abdominal tenderness. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>2.</sup> Includes upper respiratory tract infection, urinary tract infection, lung infection, pharyngitis, conjunctivitis, sinusitis, vaginal infection, sepsis. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>3.</sup> Includes neutropenia, neutrophil count decreased. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>4.</sup> Includes anemia, hematocrit decreased, hemoglobin decreased, red blood cell count decreased. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>5.</sup> Includes leukopenia, white blood cell count decreased. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>6.</sup> Includes platelet count decreased, thrombocytopenia. </td></tr><tr><td colspan="7" valign="top" align="left"><sup>7.</sup> Includes asthenia, fatigue. </td></tr></tbody></table>
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