FDA label 542dc07a-e484-4625-890f-968c43573634

WARNING: QTc PROLONGATION AND TORSADES DE POINTES EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation [see Warnings and Precautions (5.1) ] . Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc [see Warnings and Precautions (5.1) , Drug Interactions (7.1 , 7.3) ] . Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation [see Dosage and Administration (2.4) ] . WARNING: QTc PROLONGATION AND TORSADES DE POINTES See full prescribing information for complete boxed warning. EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation ( 5.1 ). Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc ( 5.1 , 7.1 , 7.3 ). Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation ( 2.4 ).

5 WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD)/Pneumonitis : Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed. ( 2.4 , 5.2 ) Cardiac Toxicity : Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity. ( 2.4 , 5.3 ) Diarrhea : Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity. ( 2.4 , 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 QTc Prolongation and Torsades de Pointes EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal. In the 250 patient subset of the pooled EXKIVITY safety population who had scheduled and unscheduled electrocardiograms (ECGs) [see Adverse Reactions (6.1) , Clinical Pharmacology (12.2) ] , 1.2% of patients had a QTc interval >500 msec and 11% of patients had a change-from-baseline QTc interval >60 msec. Grade 4 Torsades de Pointes occurred in 1 patient (0.4%). Clinical trials of EXKIVITY did not enroll patients with baseline QTc greater than 470 msec. Assess QTc and electrolytes at baseline and correct abnormalities in sodium, potassium, calcium, and magnesium prior to initiating EXKIVITY. Monitor QTc and electrolytes periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation, such as patients with congenital long QT syndrome, heart disease, severe renal impairment, or electrolyte abnormalities. Avoid use of concomitant drugs which are known to prolong the QTc interval. Avoid concomitant use of strong or moderate CYP3A inhibitors with EXKIVITY [see Drug Interactions (7.1) ] , which may further prolong the QTc [see Drug Interactions (7.3) ] . Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of the QTc prolongation [see Dosage and Administration (2.4) ] . 5.2 Interstitial Lung Disease (ILD)/Pneumonitis EXKIVITY can cause ILD/pneumonitis, which can be fatal. In the pooled EXKIVITY safety population [see Adverse Reactions (6.1) ] , ILD/pneumonitis occurred in 4.3% of patients including 0.8% Grade 3 events and 1.2% fatal events. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed [see Dosage and Administration (2.4) ] . 5.3 Cardiac Toxicity EXKIVITY can cause cardiac toxicity (including decreased ejection fraction, cardiomyopathy, and congestive heart failure) resulting in heart failure which can be fatal. In the pooled EXKIVITY safety population [see Adverse Reactions (6.1) ] , heart failure occurred in 2.7% of patients including 1.2% Grade 3 reactions, 0.4% Grade 4 reactions, and one (0.4%) fatal case of heart failure. EXKIVITY can cause QTc prolongation resulting in Torsades de Pointes [see Warnings and Precautions (5.1) ] . Atrial fibrillation (1.6%), ventricular tachycardia (0.4%), first degree atrioventricular block (0.4%), second degree atrioventricular block (0.4%), left bundle branch block (0.4%), supraventricular extrasystoles (0.4%) and ventricular extrasystoles (0.4%) also occurred in patients receiving EXKIVITY. Monitor cardiac function, including assessment of left ventricular ejection fraction at baseline and during treatment. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity [see Dosage and Administration (2.4) ] . 5.4 Diarrhea EXKIVITY can cause diarrhea, which can be severe. In the pooled EXKIVITY safety population [see Adverse Reactions (6.1) ] , diarrhea occurred in 93% of patients, including 20% Grade 3 and 0.4% Grade 4. The median time to first onset of diarrhea was 5 days but diarrhea has occurred within 24 hours after administration of EXKIVITY. In the 48% of patients whose diarrhea resolved, the median time to resolution was 3 days. Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Treat diarrhea promptly. Advise patients to start an antidiarrheal agent (e.g., loperamide) at first sign of diarrhea or increased bowel movement frequency and to increase fluid and electrolyte intake. Monitor electrolytes and withhold, reduce the dose or permanently discontinue EXKIVITY based on the severity [see Dosage and Administration (2.4) ] . 5.5 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, EXKIVITY can cause fetal harm when administered to a pregnant woman. Oral administration of mobocertinib to pregnant rats during the period of organogenesis resulted in embryolethality at maternal exposures approximately 1.7 times the human exposure based on area under the curve (AUC) at the 160 mg once daily clinical dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with EXKIVITY [see Drug Interactions (7.2) ] and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with EXKIVITY and for 1 week after the last dose of EXKIVITY [see Use in Specific Populations (8.1 , 8.3) ] .

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QTc Prolongation and Torsades de Pointes [see Warnings and Precautions (5.1) ] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2) ] Cardiac Toxicity [see Warnings and Precautions (5.3) ] Diarrhea [see Warnings and Precautions (5.4) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.5) ] The most common (>20%) adverse reactions are diarrhea, rash, stomatitis, vomiting, decreased appetite, paronychia, nausea, musculoskeletal pain, dry skin, fatigue, cough, pruritus, and decreased weight. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased red blood cells, increased creatinine, decreased magnesium and increased alanine aminotransferase. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-844-217-6468 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 pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to EXKIVITY as a single agent at a dose of 160 mg orally once daily in 256 patients, including 114 patients with EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC from Study AP32788-15-101, and patients with other solid tumors. Forty-eight percent (48%) were exposed for 6 months or longer and 12% were exposed for greater than one year. The most common (>20%) adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine, and decreased magnesium. EGFR Exon 20 Insertion Mutation-Positive Locally Advanced or Metastatic NSCLC Previously Treated with Platinum-Based Chemotherapy The safety of EXKIVITY was evaluated in a subset of patients in Study AP32788-15-101 with EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC who received prior platinum-based chemotherapy [see Clinical Studies (14) ] . Patients with a history of interstitial lung disease, drug-related pneumonitis, radiation pneumonitis that required steroid treatment; significant, uncontrolled, active cardiovascular disease; or prolonged QTc interval were excluded from enrollment in this trial. A total of 114 patients received EXKIVITY 160 mg once daily until disease progression or unacceptable toxicity; 60% were exposed for 6 months or longer and 14% were exposed for greater than 1 year. Serious adverse reactions occurred in 46% of patients who received EXKIVITY. Serious adverse reactions in ≥2% of patients included diarrhea, dyspnea, vomiting, pyrexia, acute kidney injury, nausea, pleural effusion, and cardiac failure. Fatal adverse reactions occurred in 1.8% of patients who received EXKIVITY, including cardiac failure (0.9%), and pneumonitis (0.9%). Permanent discontinuation occurred in 17% of patients who received EXKIVITY. Adverse reactions requiring permanent discontinuation of EXKIVITY in at least ≥2% of patients were diarrhea and nausea. Dosage interruptions of EXKIVITY due to an adverse reaction occurred in 51% of patients. Adverse reactions which required dosage interruption in >5% of patients included diarrhea, nausea and vomiting. Dose reductions of EXKIVITY due to an adverse reaction occurred in 25% of patients. The adverse reaction requiring dose reduction in >5% of patients was diarrhea. Table 3 summarizes the adverse reactions in Study AP32788-15-101. Table 3: Adverse Reactions (≥10%) in Patients with EGFR Exon 20 Insertion Mutation-Positive NSCLC Whose Disease Has Progressed on or after Platinum-Based Chemotherapy in Study AP32788-15-101 Adverse Reaction EXKIVITY (N = 114) All Grades Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 5) (%) Grade 3 or 4 (%) Gastrointestinal Disorders Diarrhea 92 22 Stomatitis Stomatitis includes angular cheilitis, aphthous ulcer, cheilitis, mouth ulceration, mucosal inflammation, odynophagia, and stomatitis. 46 4.4 Events of Grade 3 only (no Grade 4 occurred) Vomiting 40 2.6 Decreased appetite 39 0.9 Nausea 37 4.4 Decreased weight 21 0 Abdominal pain Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, and gastrointestinal pain. 18 1.8 Gastroesophageal reflux disease 15 0 Dyspepsia 11 0 Skin and Subcutaneous Tissue Disorders Rash Rash includes acne, dermatitis, dermatitis acneiform, rash, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, and urticaria. 78 1.8 Paronychia Paronychia includes nail bed tenderness, nail disorder, nail infection, onycholysis, and paronychia. 39 0.9 Dry skin 32 0 Pruritus 24 0.9 Alopecia 19 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain Musculoskeletal pain includes arthralgia, back pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain. 34 2.6 General Disorders and Administration Site Conditions Fatigue Fatigue includes asthenia, and fatigue. 29 3.5 Respiratory, Thoracic and Mediastinal Disorders Cough Cough includes cough, productive cough, and upper-airway cough syndrome. 24 0 Upper respiratory tract infection Upper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, and upper respiratory tract infection. 16 0 Dyspnea Dyspnea includes dyspnea, and dyspnea exertional. 15 4.4 Rhinorrhea 13 0 Eye Disorders Ocular Toxicity Ocular toxicity includes dry eye, eye pruritus, abnormal sensation in eye, eye discharge, blepharitis, trichiasis, conjunctival hemorrhage, vitreous floaters, blurred vision and corneal edema. 11 0 Cardiac Disorders QTc interval prolongation QTc interval prolongation includes electrocardiogram QT prolonged, and ventricular arrhythmia. 10 3.5 Hypertension Hypertension includes blood pressure increased, and hypertension. 10 4.4 Nervous System Disorders Headache 10 0 Clinically relevant adverse reactions in <10% of patients receiving EXKIVITY included edema (9%), acute kidney injury (8%), peripheral neuropathy (7%), palmar-plantar erythrodysesthesia (4.4%), pneumonitis (2.6%) and cardiac failure (2.6%). Table 4 summarizes the laboratory abnormalities in Study AP32788-15-101. Table 4: Select Laboratory Abnormalities (≥20%) Worsening from Baseline in Patients with EGFR Exon 20 Insertion Mutation-Positive NSCLC Whose Disease Has Progressed on or after Platinum-Based Chemotherapy in Study AP32788-15-101 Laboratory Abnormality EXKIVITY The denominator used to calculate the rate varied from 93 to 113 based on the number of patients with a baseline and at least one post-treatment value. The laboratory abnormalities are values that reflect worsening from baseline. (N = 114) All Grades Grades per NCI CTCAE v5.0 (%) Grade 3 or 4 (%) Hematology Decreased red blood cells 59 3.5 Decreased lymphocytes 52 15 Decreased platelets 26 0.9 Decreased leukocytes 25 0 Chemistry Increased creatinine 52 2.7 Increased amylase 40 13 Increased lipase 35 10 Decreased potassium 29 5 Increased alkaline phosphatase 25 1.8 Decreased albumin 23 1.8 Decreased magnesium 23 2.7 Increased alanine aminotransferase 22 2.7 Increased aspartate aminotransferase 21 1.8 Decreased sodium 20 0.9

<table width="100%"><caption>Table 3: Adverse Reactions (&#x2265;10%) in Patients with EGFR Exon 20 Insertion Mutation-Positive NSCLC Whose Disease Has Progressed on or after Platinum-Based Chemotherapy in Study AP32788-15-101</caption><col width="60%" align="left" valign="middle"/><col width="20%" align="center" valign="middle"/><col width="20%" align="center" valign="middle"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2" align="center">Adverse Reaction</th><th styleCode="Rrule" colspan="2">EXKIVITY (N = 114)</th></tr><tr><th styleCode="Rrule" align="center">All Grades <footnote>Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 5)</footnote> (%)</th><th styleCode="Rrule">Grade 3 or 4 (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Gastrointestinal Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Diarrhea</td><td styleCode="Rrule">92</td><td styleCode="Rrule">22</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Stomatitis<footnote>Stomatitis includes angular cheilitis, aphthous ulcer, cheilitis, mouth ulceration, mucosal inflammation, odynophagia, and stomatitis.</footnote></td><td styleCode="Rrule">46</td><td styleCode="Rrule">4.4<footnote ID="t3f1">Events of Grade 3 only (no Grade 4 occurred)</footnote></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Vomiting</td><td styleCode="Rrule">40</td><td styleCode="Rrule">2.6<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased appetite</td><td styleCode="Rrule">39</td><td styleCode="Rrule">0.9<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nausea</td><td styleCode="Rrule">37</td><td styleCode="Rrule">4.4<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased weight</td><td styleCode="Rrule">21</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Abdominal pain<footnote>Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, and gastrointestinal pain.</footnote></td><td styleCode="Rrule">18</td><td styleCode="Rrule">1.8<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Gastroesophageal reflux disease</td><td styleCode="Rrule">15</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dyspepsia</td><td styleCode="Rrule">11</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Rash<footnote>Rash includes acne, dermatitis, dermatitis acneiform, rash, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, and urticaria.</footnote></td><td styleCode="Rrule">78</td><td styleCode="Rrule">1.8<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Paronychia<footnote>Paronychia includes nail bed tenderness, nail disorder, nail infection, onycholysis, and paronychia.</footnote></td><td styleCode="Rrule">39</td><td styleCode="Rrule">0.9<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dry skin</td><td styleCode="Rrule">32</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pruritus</td><td styleCode="Rrule">24</td><td styleCode="Rrule">0.9<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Alopecia</td><td styleCode="Rrule">19</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Musculoskeletal and Connective Tissue Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Musculoskeletal pain<footnote>Musculoskeletal pain includes arthralgia, back pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain.</footnote></td><td styleCode="Rrule">34</td><td styleCode="Rrule">2.6<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">General Disorders and Administration Site Conditions</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Fatigue<footnote>Fatigue includes asthenia, and fatigue.</footnote></td><td styleCode="Rrule">29</td><td styleCode="Rrule">3.5<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Respiratory, Thoracic and Mediastinal Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cough<footnote>Cough includes cough, productive cough, and upper-airway cough syndrome.</footnote></td><td styleCode="Rrule">24</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Upper respiratory tract infection<footnote>Upper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, and upper respiratory tract infection.</footnote></td><td styleCode="Rrule">16</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dyspnea<footnote>Dyspnea includes dyspnea, and dyspnea exertional.</footnote></td><td styleCode="Rrule">15</td><td styleCode="Rrule">4.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Rhinorrhea</td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Eye Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Ocular Toxicity<footnote>Ocular toxicity includes dry eye, eye pruritus, abnormal sensation in eye, eye discharge, blepharitis, trichiasis, conjunctival hemorrhage, vitreous floaters, blurred vision and corneal edema.</footnote></td><td styleCode="Rrule">11</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Cardiac Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> QTc interval prolongation<footnote>QTc interval prolongation includes electrocardiogram QT prolonged, and ventricular arrhythmia.</footnote></td><td styleCode="Rrule">10</td><td styleCode="Rrule">3.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypertension <footnote>Hypertension includes blood pressure increased, and hypertension.</footnote></td><td styleCode="Rrule">10</td><td styleCode="Rrule">4.4<footnoteRef IDREF="t3f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Nervous System Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Headache</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td></tr></tbody></table>

<table width="100%"><caption>Table 4: Select Laboratory Abnormalities (&#x2265;20%) Worsening from Baseline in Patients with EGFR Exon 20 Insertion Mutation-Positive NSCLC Whose Disease Has Progressed on or after Platinum-Based Chemotherapy in Study AP32788-15-101</caption><col width="50%" align="left" valign="middle"/><col width="25%" align="center" valign="middle"/><col width="25%" align="center" valign="middle"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2" align="center">Laboratory Abnormality</th><th styleCode="Rrule" colspan="2">EXKIVITY<footnote>The denominator used to calculate the rate varied from 93 to 113 based on the number of patients with a baseline and at least one post-treatment value. The laboratory abnormalities are values that reflect worsening from baseline.</footnote> (N = 114)</th></tr><tr><th styleCode="Rrule" align="center">All Grades<footnote>Grades per NCI CTCAE v5.0</footnote> (%)</th><th styleCode="Rrule">Grade 3 or 4 (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Hematology</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased red blood cells</td><td styleCode="Rrule">59</td><td styleCode="Rrule">3.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased lymphocytes</td><td styleCode="Rrule">52</td><td styleCode="Rrule">15</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased platelets</td><td styleCode="Rrule">26</td><td styleCode="Rrule">0.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased leukocytes</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Chemistry</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased creatinine</td><td styleCode="Rrule">52</td><td styleCode="Rrule">2.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased amylase</td><td styleCode="Rrule">40</td><td styleCode="Rrule">13</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased lipase</td><td styleCode="Rrule">35</td><td styleCode="Rrule">10</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased potassium</td><td styleCode="Rrule">29</td><td styleCode="Rrule">5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased alkaline phosphatase</td><td styleCode="Rrule">25</td><td styleCode="Rrule">1.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased albumin</td><td styleCode="Rrule">23</td><td styleCode="Rrule">1.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased magnesium</td><td styleCode="Rrule">23</td><td styleCode="Rrule">2.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased alanine aminotransferase</td><td styleCode="Rrule">22</td><td styleCode="Rrule">2.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased aspartate aminotransferase</td><td styleCode="Rrule">21</td><td styleCode="Rrule">1.8</td></tr><tr><td styleCode="Lrule Rrule"> Decreased sodium</td><td styleCode="Rrule">20</td><td styleCode="Rrule">0.9</td></tr></tbody></table>