FDA label 4bcaf2f8-4193-4096-90f0-914c4267358d

5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions : Monitor for signs and symptoms during and following infusion. Discontinue LARTRUVO for Grade 3 or 4 infusion-related reactions. ( 2.2 , 2.3 , 5.1 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose. ( 5.2 , 8.1 , 8.3 ) 5.1 Infusion-Related Reactions Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade ≥3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion-related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N = 485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR [see Dosage and Administration ( 2.2 , 2.3 ) and Adverse Reactions ( 6.1 )] . 5.2 Embryo-Fetal Toxicity Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

6 ADVERSE REACTIONS The following adverse drug reactions are described elsewhere in the labeling: Infusion-Related Reactions [see Warnings and Precautions ( 5.1 )] . The most common (≥20%) adverse reactions of LARTRUVO plus doxorubicin are nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. ( 6.1 ) The most common (≥20%) laboratory abnormalities were lymphopenia, neutropenia, thrombocytopenia, hyperglycemia, elevated aPTT, hypokalemia, and hypophosphatemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 in the Warnings and Precautions section reflect exposure to LARTRUVO in 485 patients from three randomized, open-label, active-controlled clinical trials, which enrolled 256 patients with various tumors who received LARTRUVO in combination with chemotherapy (191 patients) or LARTRUVO as a single agent (65 patients); four open-label single-arm trials which enrolled 96 patients with various tumors who received LARTRUVO as a single agent at doses of 10 to 20 mg/kg; and two trials, including Trial 1, which enrolled 133 patients with soft tissue sarcoma who received LARTRUVO at doses of 15 to 20 mg/kg in combination with doxorubicin (103 patients) or LARTRUVO as a single agent (30 patients). Among the 485 patients, 25% were exposed to LARTRUVO for ≥6 months and 6% were exposed for ≥12 months. The data described below reflect exposure to LARTRUVO in 64 patients with metastatic soft tissue sarcoma enrolled in Trial 1, a multicenter, randomized (1:1), open-label, active-controlled trial comparing LARTRUVO plus doxorubicin with doxorubicin as a single agent. LARTRUVO was administered at 15 mg/kg as an intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity [see Clinical Studies ( 14 )] . All patients received doxorubicin 75 mg/m 2 as an intravenous infusion on Day 1 of each 21-day cycle for a maximum of eight cycles and received dexrazoxane, prior to doxorubicin in cycles 5 to 8. In Trial 1, no patients had received a prior anthracycline-containing regimen. The trial excluded patients with an ECOG performance status >2; left ventricular ejection fraction <50%; or unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months. Baseline demographics and disease characteristics were: median age 58 years (range 22 to 86); 45% male; 87% White, 8% Black, 3% Asian, 2% Other; 57% ECOG PS 0, 39% ECOG PS 1, and 5% ECOG PS 2. The median duration of exposure to LARTRUVO was 6 months (range: 21 days to 29.4 months) with 36 (56%) patients receiving LARTRUVO for ≥6 months and 10 (16%) patients receiving LARTRUVO for ≥12 months. The median cumulative doxorubicin dose was 488 mg/m 2 in the LARTRUVO plus doxorubicin arm and 300 mg/m 2 in the doxorubicin arm. In Trial 1, adverse reactions resulting in permanent discontinuation of LARTRUVO occurred in 8% (5/64) of patients. The most common adverse reaction leading to LARTRUVO discontinuation was infusion-related reaction (3%). Dose reductions of LARTRUVO for adverse reactions occurred in 25% (16/64) of patients; the most common adverse reaction leading to dose reduction was Grade 3 or 4 neutropenia (20%). Dose delays of LARTRUVO for adverse reactions occurred in 52% (33/64) of patients; the most common adverse reactions resulting in dose delays were neutropenia (33%), thrombocytopenia (8%), and anemia (5%). Table 1 summarizes adverse reactions that occurred in at least 10% of patients receiving LARTRUVO in the randomized portion of the study. The most common adverse reactions reported in at least 20% of patients receiving LARTRUVO plus doxorubicin were nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. Table 1: Adverse Reactions Occurring in ≥10% (All Grades) of Patients in the LARTRUVO plus Doxorubicin Arm and at a Higher Incidence than in the Doxorubicin Arm (Between Arm Difference of ≥5% for All Grades or ≥2% for Grades 3 and 4) (Trial 1) a Abdominal pain includes: abdominal pain, lower abdominal pain, and upper abdominal pain. b Fatigue includes: asthenia and fatigue. c Musculoskeletal pain includes: arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity. Adverse Reactions LARTRUVO plus Doxorubicin N=64 Doxorubicin N=65 All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Gastrointestinal Disorders Nausea 73 2 52 3 Mucositis 53 3 35 5 Vomiting 45 0 19 0 Diarrhea 34 3 23 0 Abdominal Pain a 23 3 14 0 General Disorders and Administrative Site Conditions Fatigue b 69 9 69 3 Infusion-Related Reactions 13 3 3 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal Pain c 64 8 25 2 Skin and Subcutaneous Tissue Disorders Alopecia 52 0 40 0 Metabolic and Nutritional Disorders Decreased Appetite 31 2 20 0 Nervous System Disorders Neuropathy 22 0 11 0 Headache 20 0 9 0 Psychiatric Disorder Anxiety 11 0 3 0 Eye Disorder Dry Eyes 11 0 3 0 In Trial 1, the most common laboratory abnormalities (≥20%) were lymphopenia, neutropenia, thrombocytopenia, hyperglycemia, elevated aPTT, hypokalemia, and hypophosphatemia as shown in Table 2 . Table 2: Laboratory Abnormalities Worsening from Baseline in >10% (All Grades) of Patients in the LARTRUVO plus Doxorubicin Arm and Occurring at a Higher Incidence than in the Doxorubicin Arm (Between Arm Difference ≥5% for All Grades or ≥2% for Grades 3 and 4) (Trial 1) a The incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement: LARTRUVO plus doxorubicin arm (range 60 to 63 patients) and doxorubicin arm (range 39 to 62 patients). b aPTT = activated partial thromboplastin time Laboratory Abnormality LARTRUVO plus Doxorubicin a Doxorubicin a All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) Chemistry Hyperglycemia 52 2 28 3 Increased aPTT b 33 5 13 0 Hypokalemia 21 8 15 3 Hypophosphatemia 21 5 7 3 Increased Alkaline Phosphatase 16 0 7 0 Hypomagnesemia 16 0 8 0 Hematology Lymphopenia 77 44 73 37 Neutropenia 65 48 63 38 Thrombocytopenia 63 6 44 11 6.2 Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity. In clinical trials, 13/370 (3.5%) of evaluable LARTRUVO-treated patients tested positive for treatment-emergent anti-olaratumab antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in all patients who tested positive for treatment-emergent anti-olaratumab antibodies. The effects of anti-olaratumab antibodies on efficacy, safety, and exposure could not be assessed due to the limited number of patients with treatment-emergent anti-olaratumab antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to LARTRUVO with the incidences of antibodies to other products may be misleading.

<table ID="t1" width="100%"><caption>Table 1: Adverse Reactions Occurring in &#x2265;10% (All Grades) of Patients in the LARTRUVO plus Doxorubicin Arm and at a Higher Incidence than in the Doxorubicin Arm (Between Arm Difference of &#x2265;5% for All Grades or &#x2265;2% for Grades 3 and 4) (Trial 1) </caption><col width="32.494%" align="left"/><col width="16.577%" align="left"/><col width="16.617%" align="left"/><col width="17.497%" align="left"/><col width="16.817%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">^a Abdominal pain includes: abdominal pain, lower abdominal pain, and upper abdominal pain. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">^b Fatigue includes: asthenia and fatigue. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">^c Musculoskeletal pain includes: arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity. </paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" align="center" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reactions</content></td><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">LARTRUVO plus Doxorubicin</content> <content styleCode="bold">N=64</content></td><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Doxorubicin</content> <content styleCode="bold">N=65</content></td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="middle" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3-4</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3-4</content> <content styleCode="bold">(%)</content></td></tr><tr><td colspan="5" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Gastrointestinal Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Nausea </td><td align="center" valign="top" styleCode="Botrule Rrule">73 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">52 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Mucositis </td><td align="center" valign="top" styleCode="Botrule Rrule">53 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">35 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Vomiting </td><td align="center" valign="top" styleCode="Botrule Rrule">45 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">19 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Diarrhea </td><td align="center" valign="top" styleCode="Botrule Rrule">34 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">23 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Abdominal Pain^a</td><td align="center" valign="top" styleCode="Botrule Rrule">23 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">General Disorders and Administrative Site Conditions</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Fatigue^b</td><td align="center" valign="top" styleCode="Botrule Rrule">69 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td><td align="center" valign="top" styleCode="Botrule Rrule">69 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Infusion-Related Reactions </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" 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 Pain^c</td><td align="center" valign="top" styleCode="Botrule Rrule">64 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">25 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td></tr><tr><td colspan="5" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Alopecia </td><td align="center" valign="top" styleCode="Botrule Rrule">52 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">40 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Metabolic and Nutritional Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Decreased Appetite </td><td align="center" valign="top" styleCode="Botrule Rrule">31 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">20 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Nervous System Disorders</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Neuropathy </td><td align="center" valign="top" styleCode="Botrule Rrule">22 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </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">20 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" align="justify" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Psychiatric Disorder</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Anxiety </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" align="left" valign="top" styleCode="Botrule Lrule Rrule"><content styleCode="bold">Eye Disorder</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dry Eyes </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>

<table ID="t2" width="100%"><caption>Table 2: Laboratory Abnormalities Worsening from Baseline in &gt;10% (All Grades) of Patients in the LARTRUVO plus Doxorubicin Arm and Occurring at a Higher Incidence than in the Doxorubicin Arm (Between Arm Difference &#x2265;5% for All Grades or &#x2265;2% for Grades 3 and 4) (Trial 1) </caption><col width="34.100%" align="left"/><col width="18.680%" align="left"/><col width="16.660%" align="left"/><col width="15.740%" align="left"/><col width="14.820%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">^a The incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement: LARTRUVO plus doxorubicin arm (range 60 to 63 patients) and doxorubicin arm (range 39 to 62 patients). </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">^b aPTT = activated partial thromboplastin time </paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" align="center" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Laboratory Abnormality</content></td><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">LARTRUVO plus Doxorubicin</content><content styleCode="bold">^a</content></td><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Doxorubicin</content><content styleCode="bold">^a</content></td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grades 3-4</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grades 3-4</content> <content styleCode="bold">(%)</content></td></tr><tr><td colspan="5" 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"> Hyperglycemia </td><td align="center" valign="top" styleCode="Botrule Rrule">52 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">28 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased aPTT^b</td><td align="center" valign="top" styleCode="Botrule Rrule">33 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Hypokalemia </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Hypophosphatemia </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Increased Alkaline Phosphatase </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Hypomagnesemia </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td colspan="5" 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"> Lymphopenia </td><td align="center" valign="top" styleCode="Botrule Rrule">77 </td><td align="center" valign="top" styleCode="Botrule Rrule">44 </td><td align="center" valign="top" styleCode="Botrule Rrule">73 </td><td align="center" valign="top" styleCode="Botrule Rrule">37 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Neutropenia </td><td align="center" valign="top" styleCode="Botrule Rrule">65 </td><td align="center" valign="top" styleCode="Botrule Rrule">48 </td><td align="center" valign="top" styleCode="Botrule Rrule">63 </td><td align="center" valign="top" styleCode="Botrule Rrule">38 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Thrombocytopenia </td><td align="center" valign="top" styleCode="Botrule Rrule">63 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">44 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td></tr></tbody></table>