FDA label 94544e08-d7c0-4154-aa40-46c5298c5528

5 WARNINGS AND PRECAUTIONS Stomatitis : Withhold, resume at reduced dose, or permanently discontinue based on severity. ( 5.1 ) Myelosuppression : Monitor blood counts prior to and during FYARRO treatment as clinically indicated. Withhold, resume at reduced dose, or permanently discontinue based on severity. ( 5.2 ) Infections : May result from immunosuppression. Monitor for signs and symptoms of infection. Withhold, resume at reduced dose, or permanently discontinue based on severity. ( 5.3 ) Hypokalemia and hyperglycemia : Monitor serum potassium and glucose prior to starting FYARRO and as clinically indicated. Withhold, resume at reduced dose, or permanently discontinue based on severity. ( 5.4 , 5.5 ) ILD/Non-Infectious Pneumonitis : Monitor for new or worsening respiratory symptoms or radiological changes. Withhold, resume at reduced dose, or permanently discontinue based on severity. ( 5.6 ) Hemorrhage: Monitor for signs and symptoms. Withhold, resume at reduced dose, or permanently discontinue based on severity. ( 5.7 ) Hypersensitivity Reactions : Monitor for hypersensitivity during and following each FYARRO infusion. Monitor for at least 2 hours following completion of the first infusion and as clinically indicated for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue based on severity. ( 5.8 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception. ( 5.9 ) Male Infertility : Azoospermia or oligospermia may occur. ( 5.10 ) Immunizations : Avoid live vaccines ( 5.11 ) 5.1 Stomatitis Stomatitis , including mouth ulcers and oral mucositis , occurred in 79% of patients treated with FYARRO, including 18% Grade 3. Stomatitis was most often first reported within 8 weeks of treatment. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 )] . 5.2 Myelosuppression FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 )]. 5.3 Infections FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections. Monitor patients for infections, including opportunistic infections. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 )] . 5.4 Hypokalemia FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients, including 12% Grade 3 events. Monitor potassium levels prior to starting FYARRO and implement potassium supplementation as medically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 )] . 5.5 Hyperglycemia FYARRO can cause hyperglycemia. Hyperglycemia occurred in 12% of patients treated with FYARRO, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in non-diabetic patients, or as clinically indicated. Monitor serum glucose more frequently in diabetic patients. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 )] . 5.6 Interstitial Lung Disease / Non-Infectious Pneumonitis FYARRO can cause interstitial lung disease (ILD) / non-infectious pneumonitis. ILD / non-infectious pneumonitis occurred in 18% of patients treated with FYARRO, of which all were Grades 1 or 2. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 )] . 5.7 Hemorrhage FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients treated with FYARRO, including Grade 3 and Grade 5 events in 2.9% of patients each [see Adverse Reactions ( 6.1 )] . Monitor patients for signs and symptoms of hemorrhage. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO [see Dosage and Administration ( 2.2 )] . 5.8 Hypersensitivity Reactions FYARRO can cause hypersensitivity reactions [see Contraindications ( 4 )]. Hypersensitivity reactions, including anaphylactic, angioedema, exfoliative dermatitis and hypersensitivity vasculitis have been observed with administration of the oral formulation of sirolimus. Hypersensitivity reactions including anaphylaxis have been observed with human albumin administration. Monitor patients closely for signs and symptoms of infusion reactions during and following each FYARRO infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Monitor patients for at least 2 hours after the first infusion and as clinically needed for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue FYARRO based on severity and institute appropriate medical management as needed. 5.9 Embryo-Fetal Toxicity Based on animal studies and the mechanism of action [see Clinical Pharmacology ( 12.1 )] , FYARRO can cause fetal harm when administered to a pregnant woman. In animal studies, mechanistic target of rapamycin kinase (mTOR) inhibitors caused embryo-fetal toxicity when administered during the period of organogenesis at maternal exposures that were equal to or less than human exposures at the recommended lowest starting dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to avoid becoming pregnant and to use effective contraception while using FYARRO and for 12 weeks after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] . 5.10 Male Infertility Azoospermia or oligospermia may be observed in patients treated with FYARRO [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] . FYARRO is an anti-proliferative drug and affects rapidly dividing cells such as germ cells. 5.11 Immunizations and Risks Associated with Live Vaccines No studies in conjunction with immunization have been conducted with FYARRO. Immunization during FYARRO treatment may be ineffective. Update immunizations according to immunization guidelines prior to initiating FYARRO, if possible. Immunization with live vaccines is not recommended during treatment and avoid close contact with those who have received live vaccines while on FYARRO. The interval between live vaccinations and initiation of FYARRO should be in accordance with current vaccination guidelines for patients on immunosuppressive therapies. 5.12 Risk of Transmission of Infectious Agents with Human Albumin FYARRO contains human albumin, a derivative of human blood. Human albumin carries only a remote risk of transmission of viral diseases because of effective donor screening and product manufacturing processes. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been associated with albumin.

6 ADVERSE REACTIONS The following adverse reactions have been associated with FYARRO in clinical trials and are discussed in greater detail in other sections of the label [see Warnings and Precautions ( 5 )] . Stomatitis [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Infections [see Warnings and Precautions ( 5.3 )] Hypokalemia [see Warnings and Precautions ( 5.4 )] Hyperglycemia [see Warnings and Precautions ( 5.5 )] Interstitial Lung Disease (ILD) / Non-Infectious Pneumonitis [see Warnings and Precautions ( 5.6 )] Hemorrhage [see Warnings and Precautions ( 5.7 )] Hypersensitivity [see Warnings and Precautions ( 5.8 )] The most common (≥30%) adverse reactions were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia. ( 6.1 ) The most common (≥6%) Grade 3 to 4 laboratory abnormalities were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aadi Bioscience, Inc. at 1-888-BIO-AADI (888-246-2234) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 FYARRO was assessed in a single-arm study (AMPECT). Thirty-four patients received FYARRO 100 mg/m 2 on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity [see Clinical Studies ( 14.1 )] . Among the 34 patients who received FYARRO, 16 (47%) were exposed for 6 months or longer and 7 (21%) were exposed for greater than 1 year. The median age of patients who received FYARRO was 59.5 years (range 27 to 78 years), 82% were female and Eastern Cooperative Oncology Group (ECOG) Performance Status was 0 (76%) or 1 (24%). Race was 71% White, 9% Black, 9% Asian, 3% Hawaiian/Pacific Islander and 9% Other/Not Reported. Ethnicity was 82% not Hispanic or Latino, 15% Hispanic or Latino, and 3% Not Reported. Serious adverse reactions occurred in 14 (41%) patients who received FYARRO. Serious adverse reactions in >5% of patients, including 4 (12%) patients with infection and 2 (6%) patients each with abdominal pain, dehydration, and upper gastrointestinal hemorrhage. Fatal adverse reactions occurred in 1 (2.9%) patient who received FYARRO and experienced upper gastrointestinal hemorrhage. Permanent discontinuation of FYARRO due to an adverse reaction occurred in 3 (9%) patients. Adverse reactions which resulted in permanent discontinuation of FYARRO included pneumonitis, anemia, and noninfective cystitis. Dosage interruptions of FYARRO due to an adverse reaction occurred in 22 (65%) patients. Adverse reactions which required dosage interruption in >5% of patients included stomatitis in 6 (18%) patients, pneumonitis in 5 (15%) patients, anemia in 3 (9%) patients, and dehydration, dermatitis acneiform, and thrombocytopenia in 2 (6%) patients each. Dose reductions of FYARRO due to an adverse reaction occurred in 12 (35%) patients. Adverse reactions which required dose reductions in >5% of patients included stomatitis and pneumonitis in 3 (9%) patients each. The most common adverse reactions (≥30%) were stomatitis in 27 (79%) patients, fatigue and rash in 23 (68%) patients each, infection in 20 (59%) patients, nausea and edema in 17 (50%) patients each, diarrhea, musculoskeletal pain and decreased weight in 16 (47%) patients each, decreased appetite in 15 (44%) patients, cough in 12 (35%) patients, and vomiting and dysgeusia in 11 (32%) patients each. The most common Grade 3 to 4 laboratory abnormalities (≥6%) were decreased lymphocytes in 7 (21%) patients, increased glucose and decreased potassium in 4 (12%) patients each, decreased phosphate in 3 (9%) patients, and decreased hemoglobin and increased lipase in 2 (6%) patients each. Table 4 summarizes the adverse reactions in AMPECT. Table 4. Adverse Reactions ≥10% in Patients with PEComa Who Received FYARRO in AMPECT Grading according to NCI CTCAE Version 4.03 a Includes stomatitis, aphthous ulcer, mouth ulceration, esophageal ulcer b Includes diarrhea and enteritis c Includes abdominal pain, abdominal pain upper, and epigastric discomfort d Includes face edema, generalized edema, edema, edema peripheral, and periorbital edema e Includes dermatitis acneiform, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, and skin exfoliation f Includes all reported infections, including but not limited to, upper respiratory tract infection, urinary tract infection, sinusitis , skin infection, folliculitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pneumonia, vaginal infection g Includes dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, and peripheral sensory neuropathy h Includes dizziness, dizziness postural, and vertigo i Includes arthralgia, back pain, musculoskeletal chest pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity j Includes cough, productive cough, and upper-airway cough syndrome k Includes dyspnea and dyspnea exertional l Includes epistaxis, hemorrhoidal hemorrhage, mouth hemorrhage, post procedural hemorrhage, and upper gastrointestinal hemorrhage. Includes one fatal adverse reaction of upper GI hemorrhage *No Grade 4 reactions were reported FYARRO (N=34) Adverse Reaction All Grades (%) Grade 3 to 4* (%) Gastrointestinal Stomatitis a 79 18 Nausea 50 0 Diarrhea b 47 2.9 Vomiting 32 2.9 Abdominal Pain c 29 6 Constipation 24 2.9 Dry Mouth 15 0 Hemorrhoids 12 0 General disorders Fatigue 68 2.9 Edema d 50 2.9 Pyrexia 24 0 Skin and subcutaneous tissue disorders Rash e 68 0 Alopecia 24 0 Pruritus 18 0 Dry Skin 12 0 Nail disorder 12 0 Infections Infections f 59 12 Metabolism and nutrition Decreased appetite 44 0 Dehydration 15 6 Nervous system Dysgeusia 32 0 Headache 29 0 Peripheral neuropathy g 15 0 Dizziness h 12 0 Investigations Weight decreased 47 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain i 47 2.9 Respiratory, thoracic, and mediastinal disorders Cough j 35 0 Pneumonitis 18 0 Dyspnea k 12 0 Vascular disorders Hypertension 29 2.9 Hemorrhage l 24 2.9 Psychiatric disorders Insomnia 21 2.9 Eye disorders Vision blurred 12 0 Table 5 summarizes the laboratory abnormalities in AMPECT. Table 5. Laboratory Abnormalities ≥10% That Worsened from Baseline in Patients with PEComa who Received FYARRO in AMPECT 1 Grading according to NCI CTCAE Version 4.03 2 The denominator used to calculate the rate varied from 33 to 34 based on the number of patients with a baseline value and at least one post-treatment value. FYARRO 2 (N=34) Laboratory Abnormality 1 All Grades (%) Grades 3 to 4 (%) Hematology Decreased lymphocytes 82 21 Decreased hemoglobin 68 6 Decreased leukocytes 41 0 Decreased neutrophils 35 0 Decreased platelets 35 0 Chemistry Increased creatinine 82 0 Increased triglycerides 52 0 Increased cholesterol 48 3 Increased alanine aminotransferase (ALT) 47 2.9 Decreased potassium 44 12 Decreased magnesium 42 0 Decreased albumin 35 2.9 Increased aspartate transaminase (AST) 32 2.9 Increased alkaline phosphatase 29 0 Decreased sodium 24 2.9 Decreased calcium 15 0 Decreased glucose 15 0 Decreased phosphate 15 9 Increased lipase 12 6 Increased glucose 12 12 Increased sodium 12 0 Clinically relevant adverse reactions occurring in <10% of patients included enteritis, edema, pancytopenia, acute kidney injury, and acute coronary syndrome.

<table ID="t4" width="100%"><caption>Table 4. Adverse Reactions &#x2265;10% in Patients with PEComa Who Received FYARRO in AMPECT </caption><col width="50.433%" align="left"/><col width="24.767%" align="left"/><col width="24.800%" align="left"/><tfoot><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">Grading according to NCI CTCAE Version 4.03 </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^aIncludes stomatitis, aphthous ulcer, mouth ulceration, esophageal ulcer </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^bIncludes diarrhea and enteritis </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^cIncludes abdominal pain, abdominal pain upper, and epigastric discomfort </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^dIncludes face edema, generalized edema, edema, edema peripheral, and periorbital edema </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^eIncludes dermatitis acneiform, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, and skin exfoliation </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^fIncludes all reported infections, including but not limited to, upper respiratory tract infection, urinary tract infection, sinusitis , skin infection, folliculitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pneumonia, vaginal infection </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^gIncludes dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, and peripheral sensory neuropathy </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^hIncludes dizziness, dizziness postural, and vertigo </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">ⁱIncludes arthralgia, back pain, musculoskeletal chest pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^jIncludes cough, productive cough, and upper-airway cough syndrome </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^kIncludes dyspnea and dyspnea exertional </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">^lIncludes epistaxis, hemorrhoidal hemorrhage, mouth hemorrhage, post procedural hemorrhage, and upper gastrointestinal hemorrhage. Includes one fatal adverse reaction of upper GI hemorrhage </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><paragraph styleCode="footnote">*No Grade 4 reactions were reported </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"/><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">FYARRO (N=34)</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades (%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3 to 4* (%)</content></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Gastrointestinal</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Stomatitis^a</td><td align="center" valign="top" styleCode="Botrule Rrule">79 </td><td align="center" valign="top" styleCode="Botrule Rrule">18 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Nausea </td><td align="center" valign="top" styleCode="Botrule Rrule">50 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Diarrhea^b</td><td align="center" valign="top" styleCode="Botrule Rrule">47 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Vomiting </td><td align="center" valign="top" styleCode="Botrule Rrule">32 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Abdominal Pain^c</td><td align="center" valign="top" styleCode="Botrule Rrule">29 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Constipation </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dry Mouth </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Hemorrhoids </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">General disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Fatigue </td><td align="center" valign="top" styleCode="Botrule Rrule">68 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Edema^d</td><td align="center" valign="top" styleCode="Botrule Rrule">50 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Pyrexia </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Skin and subcutaneous tissue disorders</content></td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Rash^e</td><td align="center" valign="top" styleCode="Botrule Rrule">68 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Alopecia </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Pruritus </td><td align="center" valign="top" styleCode="Botrule Rrule">18 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dry Skin </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Nail disorder </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Infections</content></td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Infections^f</td><td align="center" valign="top" styleCode="Botrule Rrule">59 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Metabolism and nutrition</content></td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased appetite </td><td align="center" valign="top" styleCode="Botrule Rrule">44 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dehydration </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Nervous system</content></td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dysgeusia </td><td align="center" valign="top" styleCode="Botrule Rrule">32 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Headache </td><td align="center" valign="top" styleCode="Botrule Rrule">29 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Peripheral neuropathy^g</td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dizziness^h</td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Investigations</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Weight decreased </td><td align="center" valign="top" styleCode="Botrule Rrule">47 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Musculoskeletal painⁱ</td><td align="center" valign="top" styleCode="Botrule Rrule">47 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Respiratory, thoracic, and mediastinal disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Cough^j</td><td align="center" valign="top" styleCode="Botrule Rrule">35 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Pneumonitis </td><td align="center" valign="top" styleCode="Botrule Rrule">18 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dyspnea^k</td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Vascular disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Hypertension </td><td align="center" valign="top" styleCode="Botrule Rrule">29 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Hemorrhage^l</td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Psychiatric disorders</content></td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Insomnia </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Eye disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Vision blurred </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>

<table ID="t5" width="100%"><caption>Table 5. Laboratory Abnormalities &#x2265;10% That Worsened from Baseline in Patients with PEComa who Received FYARRO in AMPECT </caption><col width="40.933%" align="left"/><col width="18.000%" align="left"/><col width="41.067%" align="left"/><tfoot><tr><td colspan="3" align="left" valign="top" styleCode="Lrule Rrule"><paragraph styleCode="footnote">¹Grading according to NCI CTCAE Version 4.03 </paragraph></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><paragraph styleCode="footnote">²The denominator used to calculate the rate varied from 33 to 34 based on the number of patients with a baseline value and at least one post-treatment value. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"/><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">FYARRO</content><content styleCode="bold">²</content><content styleCode="bold">(N=34)</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Laboratory Abnormality</content><content styleCode="bold">¹</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades (%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grades 3 to 4 (%)</content></td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Hematology</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased lymphocytes </td><td align="center" valign="top" styleCode="Botrule Rrule">82 </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased hemoglobin </td><td align="center" valign="top" styleCode="Botrule Rrule">68 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased leukocytes </td><td align="center" valign="top" styleCode="Botrule Rrule">41 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased neutrophils </td><td align="center" valign="top" styleCode="Botrule Rrule">35 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased platelets </td><td align="center" valign="top" styleCode="Botrule Rrule">35 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="3" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Chemistry</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased creatinine </td><td align="center" valign="top" styleCode="Botrule Rrule">82 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased triglycerides </td><td align="center" valign="top" styleCode="Botrule Rrule">52 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased cholesterol </td><td align="center" valign="top" styleCode="Botrule Rrule">48 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased alanine aminotransferase (ALT) </td><td align="center" valign="top" styleCode="Botrule Rrule">47 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased potassium </td><td align="center" valign="top" styleCode="Botrule Rrule">44 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased magnesium </td><td align="center" valign="top" styleCode="Botrule Rrule">42 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased albumin </td><td align="center" valign="top" styleCode="Botrule Rrule">35 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased aspartate transaminase (AST) </td><td align="center" valign="top" styleCode="Botrule Rrule">32 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased alkaline phosphatase </td><td align="center" valign="top" styleCode="Botrule Rrule">29 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased sodium </td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased calcium </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased glucose </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased phosphate </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased lipase </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased glucose </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased sodium </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>