YONDELIS

5 WARNINGS AND PRECAUTIONS Neutropenic sepsis: Severe, and fatal, neutropenic sepsis may occur. Monitor neutrophil count during treatment. Withhold YONDELIS for neutrophil count < 1,500/mcL ( 2.4 , 5.1 ) Rhabdomyolysis: Rhabdomyolysis may occur. Monitor creatine phosphokinase (CPK) levels prior to each administration. Withhold YONDELIS for CPK more than 2.5 times the upper limit of normal. ( 2.4 , 5.2 ) Hepatotoxicity: Hepatotoxicity may occur. Monitor and delay and/or reduce dose if needed ( 5.3 ) Cardiomyopathy: Severe and fatal cardiomyopathy can occur. Patients with left ventricular ejection fraction (LVEF) < lower limit of normal, prior cumulative anthracycline dose of ≥300 mg/m 2 , age ≥65 years, or a history of cardiovascular disease may be at increased risk of developing new or worsening cardiac dysfunction. Discontinue YONDELIS in patients who develop decreased LVEF or cardiomyopathy ( 2.4 , 5.4 ) Capillary leak syndrome: Monitor and discontinue YONDELIS for capillary leak syndrome ( 5.5 ) Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use effective contraception ( 5.7 , 8.1 , 8.3 ) 5.1 Neutropenic Sepsis Neutropenic sepsis, including fatal cases, can occur with YONDELIS. In Trial ET743-SAR-3007, the incidence of Grade 3 or 4 neutropenia, based on laboratory values, in patients receiving YONDELIS was 43% (161/378). The median time to the first occurrence of Grade 3 or 4 neutropenia was 16 days (range: 8 days to 9.7 months); the median time to complete resolution of neutropenia was 13 days (range: 3 days to 2.3 months). Febrile neutropenia (fever ≥38.5 °C with Grade 3 or 4 neutropenia) occurred in 18 patients (5%) treated with YONDELIS. Ten patients (2.6%) experienced neutropenic sepsis, 5 of whom had febrile neutropenia, which was fatal in 4 patients (1.1%). Assess neutrophil count prior to administration of each dose of YONDELIS and periodically throughout the treatment cycle. Withhold or reduce dose of YONDELIS based on severity of adverse reaction [see Dosage and Administration (2.4) ] . 5.2 Rhabdomyolysis YONDELIS can cause rhabdomyolysis and musculoskeletal toxicity. In Trial ET743-SAR-3007, rhabdomyolysis leading to death occurred in 3 (0.8%) of the 378 patients receiving YONDELIS. Elevations in creatine phosphokinase (CPK) occurred in 122 (32%) of the 378 patients receiving YONDELIS, including Grade 3 or 4 CPK elevation in 24 patients (6%), compared to 15 (9%) of the 172 patients receiving dacarbazine with any CPK elevation, including 1 patient (0.6%) with Grade 3 CPK elevation. Among the 24 patients receiving YONDELIS with Grade 3 or 4 CPK elevation, renal failure occurred in 11 patients (2.9%); rhabdomyolysis with the complication of renal failure occurred in 4 of these 11 patients (1.1%). The median time to first occurrence of Grade 3 or 4 CPK elevations was 2 months (range: 1 to 11.5 months). The median time to complete resolution was 14 days (range: 5 days to 1 month). Assess CPK levels prior to each administration of YONDELIS. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction [see Dosage and Administration (2.4) ] . 5.3 Hepatotoxicity Hepatotoxicity, including hepatic failure, can occur with YONDELIS. Patients with serum bilirubin levels above the upper limit of normal or AST or ALT levels >2.5 × upper limit of normal were not enrolled in Trial ET743-SAR-3007. In Trial ET743-SAR-3007, the incidence of Grade 3–4 elevated liver function tests (LFTs; defined as elevations in ALT, AST, total bilirubin, or alkaline phosphatase) was 35% (134/378) in patients receiving YONDELIS. The median time to development of Grade 3–4 elevation in ALT or AST was 29 days (range: 3 days to 11.5 months). Of the 134 patients with Grade 3–4 elevations in LFTs, 114 (85%) experienced complete resolution with the median time to complete resolution of 13 days (range: 4 days to 4.4 months). In Trial ET743-SAR-3007, the incidence of drug-induced liver injury (defined as concurrent elevation in ALT or AST of more than three times the upper limit of normal, alkaline phosphatase less than two times the upper limit of normal, and total bilirubin at least two times the upper limit of normal) was 1.3% (5/378) in patients receiving YONDELIS. ALT or AST elevation greater than eight times the upper limit of normal occurred in 18% (67/378) of patients receiving YONDELIS. Assess LFTs prior to each administration of YONDELIS and as clinically indicated based on underlying severity of pre-existing hepatic impairment. Manage elevated LFTs with treatment interruption, dose reduction, or permanent discontinuation based on severity and duration of LFT abnormality [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ]. 5.4 Cardiomyopathy Cardiomyopathy including cardiac failure, congestive heart failure, ejection fraction decreased, diastolic dysfunction, or right ventricular dysfunction can occur with YONDELIS. In Trial ET743-SAR-3007, a significant decrease in LVEF was defined as an absolute decrease of ≥15% or below the lower limit of normal with an absolute decrease of ≥5%. Patients with a history of New York Heart Association Class II to IV heart failure or abnormal left ventricular ejection fraction (LVEF) at baseline were ineligible. In Trial ET743-SAR-3007, cardiomyopathy occurred in 23 patients (6%) receiving YONDELIS and in four patients (2.3%) receiving dacarbazine. Grade 3 or 4 cardiomyopathy occurred in 15 patients (4%) receiving YONDELIS and 2 patients (1.2%) receiving dacarbazine; cardiomyopathy leading to death occurred in 1 patient (0.3%) receiving YONDELIS and in none of the patients receiving dacarbazine. The median time to development of Grade 3 or 4 cardiomyopathy in patients receiving YONDELIS was 5.3 months (range: 26 days to 15.3 months). Patients with LVEF < lower limit of normal, prior cumulative anthracycline dose of ≥300 mg/m 2 , age ≥65 years, or a history of cardiovascular disease may be at increased risk of cardiac dysfunction. Assess LVEF by echocardiogram (ECHO) or multigated acquisition (MUGA) scan before initiation of YONDELIS and at 2- to 3-month intervals thereafter until YONDELIS is discontinued. Discontinue treatment with YONDELIS based on severity of adverse reaction [see Dosage and Administration (2.4) ] . 5.5 Capillary Leak Syndrome Capillary leak syndrome (CLS) characterized by hypotension, edema, and hypoalbuminemia has been reported with YONDELIS, including serious CLS resulting in death. Monitor for signs and symptoms of CLS. Discontinue YONDELIS and promptly initiate standard management for patients with CLS, which may include a need for intensive care [see Adverse Reactions (6.2) ] . 5.6 Extravasation Resulting in Tissue Necrosis Extravasation of YONDELIS, resulting in tissue necrosis requiring debridement, can occur. Evidence of tissue necrosis can occur more than 1 week after the extravasation. There is no specific antidote for extravasation of YONDELIS. Administer YONDELIS through a central venous line [see Dosage and Administration (2.6) ] . 5.7 Embryo-Fetal Toxicity Based on its mechanism of action, YONDELIS can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during therapy and for at least 8 months after the last dose of YONDELIS. Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 5 months after the last dose of YONDELIS [see Use in Specific Populations (8.1 , 8.3) ] .

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Anaphylaxis [see Contraindications (4) ] Neutropenic Sepsis [see Warnings and Precautions (5.1) ] Rhabdomyolysis [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Cardiomyopathy [see Warnings and Precautions (5.4) ] Capillary Leak Syndrome [see Warnings and Precautions (5.5) ] Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.6) ] The most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache. The most common (≥5%) grades 3–4 laboratory abnormalities are: neutropenia, increased ALT, thrombocytopenia, anemia, increased AST, and increased creatine phosphokinase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 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 data described below reflect exposure to YONDELIS in 755 patients with soft tissue sarcoma including 197 (26%) patients exposed to YONDELIS for greater than or equal to 6 months and 57 (8%) patients exposed to YONDELIS for greater than or equal to 1 year. The safety of YONDELIS was evaluated in six open-label, single-arm trials, in which 377 patients received YONDELIS and one open-label, randomized, active-controlled clinical trial in which 378 patients received YONDELIS (Trial ET743-SAR-3007). All patients received YONDELIS at the recommended dosing regimen of 1.5 mg/m 2 administered as an intravenous infusion over 24 hours once every 3 weeks (q3wk, 24-h). The median age was 54 years (range: 18 to 81 years), 63% were female, and all patients had metastatic soft tissue sarcoma. Tables 3 and 4 present selected adverse reactions and laboratory abnormalities, respectively, observed in Trial ET743-SAR-3007, an open-label, randomized (2:1), active-controlled trial in which 550 patients with previously treated leiomyosarcoma or liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) received YONDELIS 1.5 mg/m 2 intravenous infusion over 24 hours once every 3 weeks (n=378) or dacarbazine 1000 mg/m 2 intravenous infusion over 20 to 120 minutes once every 3 weeks (n=172) [see Clinical Studies (14) ] . All patients treated with YONDELIS were required to receive dexamethasone 20 mg intravenous injection 30 minutes prior to start of the YONDELIS infusion. In Trial ET743-SAR-3007, patients had been previously treated with an anthracycline- and ifosfamide-containing regimen or with an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen. The trial excluded patients with known central nervous system metastasis, elevated serum bilirubin or significant chronic liver disease, such as cirrhosis or active hepatitis, and history of myocardial infarction within 6 months, history of New York Heart Association Class II to IV heart failure, or abnormal left ventricular ejection fraction at baseline. The median age of patients in Trial ET743-SAR-3007 was 57 years (range: 17 to 81 years), with 69% female, 77% White, 12% Black or African American, 4% Asian, and <1% American Indian or Alaska Native. The median duration of exposure to trabectedin was 13 weeks (range: 1 to 127 weeks) with 30% of patients exposed to YONDELIS for greater than 6 months and 7% of patients exposed to YONDELIS for greater than 1 year. In Trial ET743-SAR-3007, adverse reactions resulting in permanent discontinuation of YONDELIS occurred in 26% (98/378) of patients; the most common were increased liver tests (defined as ALT, AST, alkaline phosphatase, bilirubin) (5.6%), thrombocytopenia (3.4%), fatigue (1.6%), increased creatine phosphokinase (1.1%), and decreased ejection fraction (1.1%). Adverse reactions that led to dose reductions occurred in 42% (158/378) of patients treated with YONDELIS; the most common were increased liver tests (24%), neutropenia (including febrile neutropenia) (8%), thrombocytopenia (4.2%), fatigue (3.7%), increased creatine phosphokinase (2.4%), nausea (1.1%), and vomiting (1.1%). Adverse reactions led to dose interruptions in 52% (198/378) of patients treated with YONDELIS; the most common were neutropenia (31%), thrombocytopenia (15%), increased liver tests (6%), fatigue (2.9%), anemia (2.6%), increased creatinine (1.1%), and nausea (1.1%). The most common adverse reactions (≥20%) were nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache. The most common laboratory abnormalities (≥20%) were increases in AST or ALT, increased alkaline phosphatase, hypoalbuminemia, increased creatinine, increased creatine phosphokinase, anemia, neutropenia, and thrombocytopenia. Table 3: Selected Adverse Reactions Limited to adverse reactions at a rate of ≥10% in the trabectedin arm and at a rate higher in the trabectedin arm compared with dacarbazine arm by ≥5% in overall incidence or by ≥2% for Grade 3–4 adverse reactions. Occurring in ≥10% of Patients Receiving YONDELIS and at a Higher Incidence than in the Control Arm - Trial ET743-SAR-3007 YONDELIS (N=378) Dacarbazine (N=172) System Organ Class Adverse Reaction All Grades Toxicity grade is based on NCI common toxicity criteria, version 4.0. (%) Grades 3–4 (%) All Grades (%) Grades 3–4 (%) Gastrointestinal disorders Nausea 75 7 50 1.7 Vomiting 46 6 22 1.2 Constipation 37 0.8 31 0.6 Diarrhea 35 1.6 23 0 General disorders and administration site conditions Fatigue Fatigue is a composite of the following adverse event terms: fatigue, asthenia, and malaise. 69 8 52 1.7 Peripheral edema 28 0.8 13 0.6 Metabolism and nutrition disorders Decreased appetite 37 1.9 21 0.6 Respiratory, thoracic and mediastinal disorders Dyspnea 25 4.2 20 1.2 Nervous system disorders Headache 25 0.3 19 0 Musculoskeletal and connective tissue disorders Arthralgia 15 0 8 1.2 Myalgia 12 0 6 0 Psychiatric disorders Insomnia 15 0.3 9 0 Other clinically important adverse reactions observed in <10% of patients (N=755) with soft tissue sarcoma receiving YONDELIS were: Nervous system disorders : peripheral neuropathy, paresthesia, hypoesthesia. Respiratory, thoracic, and mediastinal disorders : pulmonary embolism. General disorders and administration site conditions : mucosal inflammation Table 4: Incidence of Selected Treatment-Emergent Laboratory Abnormalities Treatment-emergent laboratory abnormalities including those higher in the trabectedin arm compared with the dacarbazine arm by ≥5% (all Grades) or by ≥2% (Grade 3–4). Incidence based on number of patients who had both baseline and at least one on-study laboratory measurement. - Trial ET743-SAR-3007 Laboratory Abnormalities YONDELIS Dacarbazine All Grades (%) Grades 3–4 (%) All Grades (%) Grades 3–4 (%) YONDELIS group (range: 373 to 377 patients) and dacarbazine group (range: 166 to 168 patients). Chemistry Increased ALT 90 31 33 0.6 Increased AST 84 17 32 1.2 Increased alkaline phosphatase 70 1.6 60 0.6 Hypoalbuminemia 63 3.7 51 3.0 Increased creatinine 46 4.2 29 1.2 Increased creatine phosphokinase 33 6.4 9 0.6 Hyperbilirubinemia 13 1.9 5 0.6 Hematology Anemia 96 19 79 12 Neutropenia 66 43 47 26 Thrombocytopenia 59 21 57 20 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of YONDELIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Vascular disorders : capillary leak syndrome

<table width="90%" ID="t3"><caption>Table 3: Selected Adverse Reactions <footnote ID="K1153">Limited to adverse reactions at a rate of &#x2265;10% in the trabectedin arm and at a rate higher in the trabectedin arm compared with dacarbazine arm by &#x2265;5% in overall incidence or by &#x2265;2% for Grade 3&#x2013;4 adverse reactions.</footnote>Occurring in &#x2265;10% of Patients Receiving YONDELIS and at a Higher Incidence than in the Control Arm - Trial ET743-SAR-3007 </caption><col width="24%" align="left" valign="top"/><col width="19%" align="center" valign="top"/><col width="19%" align="center" valign="top"/><col width="19%" align="center" valign="top"/><col width="19%" align="center" valign="top"/><thead><tr><th styleCode="Lrule Rrule"/><th colspan="2" styleCode="Rrule Botrule">YONDELIS (N=378) </th><th colspan="2" styleCode="Rrule Botrule">Dacarbazine (N=172) </th></tr><tr><th styleCode="Lrule Rrule">System Organ Class Adverse Reaction </th><th align="center" styleCode="Rrule">All Grades <footnote ID="K1202">Toxicity grade is based on NCI common toxicity criteria, version 4.0.</footnote> (%) </th><th styleCode="Rrule">Grades 3&#x2013;4 (%) </th><th styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule">Grades 3&#x2013;4 (%) </th></tr></thead><tbody><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Gastrointestinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nausea</td><td styleCode="Rrule">75</td><td styleCode="Rrule">7</td><td styleCode="Rrule">50</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Vomiting</td><td styleCode="Rrule">46</td><td styleCode="Rrule">6</td><td styleCode="Rrule">22</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Constipation</td><td styleCode="Rrule">37</td><td styleCode="Rrule">0.8</td><td styleCode="Rrule">31</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Diarrhea</td><td styleCode="Rrule">35</td><td styleCode="Rrule">1.6</td><td styleCode="Rrule">23</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">General disorders and administration site conditions</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Fatigue <footnote ID="K1311">Fatigue is a composite of the following adverse event terms: fatigue, asthenia, and malaise.</footnote></td><td styleCode="Rrule">69</td><td styleCode="Rrule">8</td><td styleCode="Rrule">52</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Peripheral edema</td><td styleCode="Rrule">28</td><td styleCode="Rrule">0.8</td><td styleCode="Rrule">13</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Metabolism and nutrition disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased appetite</td><td styleCode="Rrule">37</td><td styleCode="Rrule">1.9</td><td styleCode="Rrule">21</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dyspnea</td><td styleCode="Rrule">25</td><td styleCode="Rrule">4.2</td><td styleCode="Rrule">20</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Nervous system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Headache</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0.3</td><td styleCode="Rrule">19</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Arthralgia</td><td styleCode="Rrule">15</td><td styleCode="Rrule">0</td><td styleCode="Rrule">8</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Myalgia</td><td styleCode="Rrule">12</td><td styleCode="Rrule">0</td><td styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td colspan="5" styleCode="Lrule Rrule"><content styleCode="bold">Psychiatric disorders</content></td></tr><tr><td styleCode="Lrule Rrule"> Insomnia</td><td styleCode="Rrule">15</td><td styleCode="Rrule">0.3</td><td styleCode="Rrule">9</td><td styleCode="Rrule">0</td></tr></tbody></table>

<table width="90%" ID="t4"><caption>Table 4: Incidence of Selected Treatment-Emergent Laboratory Abnormalities <footnote ID="K1505">Treatment-emergent laboratory abnormalities including those higher in the trabectedin arm compared with the dacarbazine arm by &#x2265;5% (all Grades) or by &#x2265;2% (Grade 3&#x2013;4). Incidence based on number of patients who had both baseline and at least one on-study laboratory measurement.</footnote>- Trial ET743-SAR-3007 </caption><col width="28%" align="left" valign="top"/><col width="18%" align="center" valign="top"/><col width="18%" align="center" valign="top"/><col width="18%" align="center" valign="top"/><col width="18%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th rowspan="2" styleCode="Lrule Rrule" valign="middle">Laboratory Abnormalities</th><th colspan="2" styleCode="Rrule">YONDELIS</th><th colspan="2" styleCode="Rrule">Dacarbazine</th></tr><tr styleCode="Botrule"><th align="center" styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule Toprule">Grades 3&#x2013;4 (%) </th><th styleCode="Rrule">All Grades (%) </th><th styleCode="Rrule">Grades 3&#x2013;4 (%) </th></tr></thead><tfoot><tr><td align="left" colspan="5">YONDELIS group (range: 373 to 377 patients) and dacarbazine group (range: 166 to 168 patients).</td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule"> Chemistry</td><td/><td/><td/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased ALT</td><td styleCode="Rrule">90</td><td styleCode="Rrule">31</td><td styleCode="Rrule">33</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased AST</td><td styleCode="Rrule">84</td><td styleCode="Rrule">17</td><td styleCode="Rrule">32</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased alkaline phosphatase</td><td styleCode="Rrule">70</td><td styleCode="Rrule">1.6</td><td styleCode="Rrule">60</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypoalbuminemia</td><td styleCode="Rrule">63</td><td styleCode="Rrule">3.7</td><td styleCode="Rrule">51</td><td styleCode="Rrule">3.0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased creatinine</td><td styleCode="Rrule">46</td><td styleCode="Rrule">4.2</td><td styleCode="Rrule">29</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Increased creatine phosphokinase</td><td styleCode="Rrule">33</td><td styleCode="Rrule">6.4</td><td styleCode="Rrule">9</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hyperbilirubinemia</td><td styleCode="Rrule">13</td><td styleCode="Rrule">1.9</td><td styleCode="Rrule">5</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule"> Hematology</td><td/><td/><td/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Anemia</td><td styleCode="Rrule">96</td><td styleCode="Rrule">19</td><td styleCode="Rrule">79</td><td styleCode="Rrule">12</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Neutropenia</td><td styleCode="Rrule">66</td><td styleCode="Rrule">43</td><td styleCode="Rrule">47</td><td styleCode="Rrule">26</td></tr><tr><td styleCode="Lrule Rrule"> Thrombocytopenia</td><td styleCode="Rrule">59</td><td styleCode="Rrule">21</td><td styleCode="Rrule">57</td><td styleCode="Rrule">20</td></tr></tbody></table>