Home FDA labels 26567d69-d05c-44e5-b3ca-e4504aa3c8a6 Paclitaxel openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Paclitaxel
Generic name PACLITAXEL
Manufacturer Teva Parenteral Medicines, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID e4be6cbf-72b9-4f7f-9b1b-459b2d35961a
SPL ID 26567d69-d05c-44e5-b3ca-e4504aa3c8a6
Version 12
Effective date 2026-09-09
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boxed warning WARNING Paclitaxel injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel injection should not be rechallenged with the drug. Paclitaxel injection therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel injection.
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warnings WARNINGS Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel injection should not be rechallenged with the drug. Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity. Neutrophil nadirs occurred at a median of 11 days. Paclitaxel injection should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm 3 (< 1000 cells/mm 3 for patients with KS). Frequent monitoring of blood counts should be instituted during paclitaxel injection treatment. Patients should not be re-treated with subsequent cycles of paclitaxel injection until neutrophils recover to a level > 1500 cells/mm 3 (> 1000 cells/mm 3 for patients with KS) and platelets recover to a level > 100,000 cells/mm 3 . Severe conduction abnormalities have been documented in < 1% of patients during paclitaxel injection therapy and in some cases requiring pacemaker placement. If patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel injection. Pregnancy Paclitaxel injection can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m 2 basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, and increased fetal deaths. Maternal toxicity was also observed at this dose. No teratogenic effects were observed at 1 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m 2 basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality. There are no adequate and well-controlled studies in pregnant women. If paclitaxel injection is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
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adverse reactions table <table><caption>TABLE 13: FREQUENCY<sup>a</sup> OF IMPORTANT SEVERE<sup>b</sup> ADVERSE EVENTS IN THE PHASE 3 ADJUVANT BREAST CARCINOMA STUDY</caption><col/><col/><col/><col/><col/><col/><tbody><tr><td styleCode=" Toprule"/><td styleCode=" Toprule"/><td align="center" colspan="4" styleCode=" Botrule"><paragraph>Percent of Patients</paragraph></td></tr><tr><td/><td/><td align="center" colspan="2" styleCode=" Botrule"><paragraph>Early Population</paragraph></td><td align="center" colspan="2" styleCode=" Botrule"><paragraph>Total Population</paragraph></td></tr><tr><td styleCode=" Botrule"/><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>AC<sup>c</sup> (n = 166)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>AC<sup>c</sup> followed by T<sup>d</sup> (n = 159)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>AC<sup>c</sup> (n = 1551)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>AC<sup>c</sup> followed by T<sup>d</sup> (n = 1570)</paragraph></td></tr><tr><td colspan="6"><paragraph><content styleCode="bold">• <content styleCode="italics">Bone Marrow</content><sup>e</sup></content></paragraph></td></tr><tr><td><paragraph> —Neutropenia</paragraph></td><td><paragraph>< 500/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>79</paragraph></td><td align="center"><paragraph>76</paragraph></td><td align="center"><paragraph>48</paragraph></td><td align="center"><paragraph>50</paragraph></td></tr><tr><td><paragraph> —Thrombocytopenia</paragraph></td><td><paragraph>< 50,000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>27</paragraph></td><td align="center"><paragraph>25</paragraph></td><td align="center"><paragraph>11</paragraph></td><td align="center"><paragraph>11</paragraph></td></tr><tr><td><paragraph> —Anemia</paragraph></td><td><paragraph>< 8 g/dL</paragraph></td><td align="center"><paragraph>17</paragraph></td><td align="center"><paragraph>21</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>8</paragraph></td></tr><tr><td><paragraph> —Infections</paragraph></td><td/><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>14</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>6</paragraph></td></tr><tr><td colspan="2"><paragraph> —Fever Without Infection</paragraph></td><td align="center"><paragraph>—</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>< 1</paragraph></td><td align="center"><paragraph>1</paragraph></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">• <content styleCode="italics">Hypersensitivity Reaction</content><sup>f</sup></content></paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Cardiovascular Events</content></content></paragraph></td><td/><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Neuromotor Toxicity</content></content></paragraph></td><td/><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>< 1</paragraph></td><td align="center"><paragraph>1</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Neurosensory Toxicity</content></content></paragraph></td><td/><td align="center"><paragraph>—</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>< 1</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">• Myalgia/Arthralgia</content></content></paragraph></td><td/><td align="center"><paragraph>—</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>< 1</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">• Nausea/Vomiting</content></content></paragraph></td><td/><td align="center"><paragraph>13</paragraph></td><td align="center"><paragraph>18</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td styleCode=" Botrule"><paragraph><content styleCode="bold"><content styleCode="italics">• Mucositis</content></content></paragraph></td><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>13</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>4</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>6</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>5</paragraph></td></tr><tr><td colspan="6"><paragraph><sup>a</sup> Based on worst course analysis.</paragraph></td></tr><tr><td colspan="6"><paragraph><sup>b</sup> Severe events are defined as at least Grade III toxicity.</paragraph></td></tr><tr><td colspan="6"><paragraph><sup>c</sup> Patients received 600 mg/m<sup>2</sup> cyclophosphamide and doxorubicin (AC) at doses of either 60 mg/m<sup>2</sup>, 75 mg/m<sup>2</sup>, or 90 mg/m<sup>2</sup> (with prophylactic G-CSF support and ciprofloxacin), every 3 weeks for 4 courses.</paragraph></td></tr><tr><td colspan="6"><paragraph><sup>d</sup> Paclitaxel (T) following 4 courses of AC at a dose of 175 mg/m<sup>2</sup>/3 hours every 3 weeks for 4 courses.</paragraph></td></tr><tr><td colspan="6"><paragraph><sup>e</sup> The incidence of febrile neutropenia was not reported in this study.</paragraph></td></tr><tr><td colspan="6" styleCode=" Botrule"><paragraph><sup>f</sup> All patients were to receive premedication.</paragraph></td></tr></tbody></table>
adverse reactions table <table><caption>TABLE 14: FREQUENCY<sup>a</sup> OF IMPORTANT ADVERSE EVENTS IN THE PHASE 3 STUDY OF BREAST CANCER AFTER FAILURE OF INITIAL CHEMOTHERAPY OR WITHIN 6 MONTHS OF ADJUVANT CHEMOTHERAPY</caption><col/><col/><col/><col/><tbody><tr><td styleCode=" Toprule"/><td styleCode=" Toprule"/><td align="center" colspan="2" styleCode=" Botrule"><paragraph>Percent of Patients</paragraph></td></tr><tr><td styleCode=" Botrule"/><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>175/3<sup>b</sup> (n = 229)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>135/3<sup>b</sup> (n = 229)</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Bone Marrow</content></content></paragraph></td><td/><td/><td/></tr><tr><td><paragraph> —Neutropenia</paragraph></td><td><paragraph>< 2000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>90</paragraph></td><td align="center"><paragraph>81</paragraph></td></tr><tr><td/><td><paragraph>< 500/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>28</paragraph></td><td align="center"><paragraph>19</paragraph></td></tr><tr><td><paragraph> —Thrombocytopenia</paragraph></td><td><paragraph>< 100,000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>11</paragraph></td><td align="center"><paragraph>7</paragraph></td></tr><tr><td/><td><paragraph>< 50,000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph> —Anemia</paragraph></td><td><paragraph>< 11 g/dL</paragraph></td><td align="center"><paragraph>55</paragraph></td><td align="center"><paragraph>47</paragraph></td></tr><tr><td/><td><paragraph>< 8 g/dL</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph> —Infections</paragraph></td><td/><td align="center"><paragraph>23</paragraph></td><td align="center"><paragraph>15</paragraph></td></tr><tr><td><paragraph> —Febrile Neutropenia</paragraph></td><td/><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Hypersensitivity Reaction</content><sup>c</sup></content></paragraph></td><td/></tr><tr><td><paragraph> —All</paragraph></td><td/><td align="center"><paragraph>36</paragraph></td><td align="center"><paragraph>31</paragraph></td></tr><tr><td><paragraph> —Severe<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>< 1</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Peripheral Neuropathy</content></content></paragraph></td><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>70</paragraph></td><td align="center"><paragraph>46</paragraph></td></tr><tr><td><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Mucositis</content></content></paragraph></td><td/><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>23 </paragraph></td><td align="center"><paragraph>17</paragraph></td></tr><tr><td styleCode=" Botrule"><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>3</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>< 1</paragraph></td></tr><tr><td colspan="4"><paragraph><sup>a</sup> Based on worst course analysis.</paragraph></td></tr><tr><td colspan="4"><paragraph><sup>b</sup> Paclitaxel dose in mg/m<sup>2</sup>/infusion duration in hours.</paragraph></td></tr><tr><td colspan="4"><paragraph><sup>c</sup> All patients received premedication.</paragraph></td></tr><tr><td colspan="4" styleCode=" Botrule"><paragraph><sup>†</sup> Severe events are defined as at least Grade III toxicity.</paragraph></td></tr></tbody></table>
adverse reactions table <table><caption>TABLE 15: FREQUENCY<sup>a</sup> OF IMPORTANT ADVERSE EVENTS IN THE PHASE 3 STUDY FOR FIRST-LINE NSCLC</caption><col/><col/><col/><col/><col/><tbody><tr><td styleCode=" Toprule"/><td styleCode=" Toprule"/><td align="center" colspan="3" styleCode=" Botrule"><paragraph>Percent of Patients</paragraph></td></tr><tr><td styleCode=" Botrule"/><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>T135/24<sup>b</sup> c75 (n = 195)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>T250/24<sup>c</sup> c75 (n = 197)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>VP100<sup>d</sup> c75 (n = 196)</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Bone Marrow</content></content></paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> —Neutropenia</paragraph></td><td><paragraph>< 2000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>89</paragraph></td><td align="center"><paragraph>86</paragraph></td><td align="center"><paragraph>84</paragraph></td></tr><tr><td/><td><paragraph>< 500/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>74<sup>e</sup></paragraph></td><td align="center"><paragraph>65</paragraph></td><td align="center"><paragraph>55</paragraph></td></tr><tr><td><paragraph> —Thrombocytopenia</paragraph></td><td><paragraph>< normal</paragraph></td><td align="center"><paragraph>48</paragraph></td><td align="center"><paragraph>68</paragraph></td><td align="center"><paragraph>62</paragraph></td></tr><tr><td/><td><paragraph>< 50,000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>12</paragraph></td><td align="center"><paragraph>16</paragraph></td></tr><tr><td><paragraph> —Anemia</paragraph></td><td><paragraph>< normal</paragraph></td><td align="center"><paragraph>94</paragraph></td><td align="center"><paragraph>96</paragraph></td><td align="center"><paragraph>95</paragraph></td></tr><tr><td/><td><paragraph>< 8 g/dL</paragraph></td><td align="center"><paragraph>22</paragraph></td><td align="center"><paragraph>19</paragraph></td><td align="center"><paragraph>28</paragraph></td></tr><tr><td><paragraph> —Infections</paragraph></td><td/><td align="center"><paragraph>38</paragraph></td><td align="center"><paragraph>31</paragraph></td><td align="center"><paragraph>35</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Hypersensitivity Reaction</content><sup>f</sup></content></paragraph></td><td/><td/></tr><tr><td><paragraph> —All</paragraph></td><td/><td align="center"><paragraph>16</paragraph></td><td align="center"><paragraph>27</paragraph></td><td align="center"><paragraph>13</paragraph></td></tr><tr><td><paragraph> —Severe<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>4<sup>e</sup></paragraph></td><td align="center"><paragraph>1</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Arthralgia/Myalgia</content></content></paragraph></td><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>21<sup>e</sup></paragraph></td><td align="center"><paragraph>42<sup>e</sup></paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>11</paragraph></td><td align="center"><paragraph>1</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Nausea/Vomiting</content></content></paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>85</paragraph></td><td align="center"><paragraph>87</paragraph></td><td align="center"><paragraph>81</paragraph></td></tr><tr><td><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>27</paragraph></td><td align="center"><paragraph>29</paragraph></td><td align="center"><paragraph>22</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Mucositis</content></content></paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>18</paragraph></td><td align="center"><paragraph>28</paragraph></td><td align="center"><paragraph>16</paragraph></td></tr><tr><td><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Neuromotor Toxicity</content></content></paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>37</paragraph></td><td align="center"><paragraph>47</paragraph></td><td align="center"><paragraph>44</paragraph></td></tr><tr><td><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>12</paragraph></td><td align="center"><paragraph>7</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Neurosensory Toxicity</content></content></paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>48</paragraph></td><td align="center"><paragraph>61</paragraph></td><td align="center"><paragraph>25</paragraph></td></tr><tr><td><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>13</paragraph></td><td align="center"><paragraph>28<sup>e</sup></paragraph></td><td align="center"><paragraph>8</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Cardiovascular Events</content></content></paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> —Any symptoms</paragraph></td><td/><td align="center"><paragraph>33</paragraph></td><td align="center"><paragraph>39</paragraph></td><td align="center"><paragraph>24</paragraph></td></tr><tr><td styleCode=" Botrule"><paragraph> —Severe symptoms<sup>†</sup></paragraph></td><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>13</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>12</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>8</paragraph></td></tr><tr><td colspan="5"><paragraph><sup>a</sup> Based on worst course analysis.</paragraph></td></tr><tr><td colspan="5"><paragraph><sup>b</sup> Paclitaxel (T) dose in mg/m<sup>2</sup>/infusion duration in hours; cisplatin (c) dose in mg/m<sup>2</sup>.</paragraph></td></tr><tr><td colspan="5"><paragraph><sup>c</sup> Paclitaxel dose in mg/m<sup>2</sup>/infusion duration in hours with G-CSF support; cisplatin dose in mg/m<sup>2</sup>.</paragraph></td></tr><tr><td colspan="5"><paragraph><sup>d</sup> Etoposide (VP) dose in mg/m<sup>2</sup> was administered IV on days 1, 2, and 3; cisplatin dose in mg/m<sup>2</sup>.</paragraph></td></tr><tr><td colspan="5"><paragraph><sup>e</sup> p < 0.05.</paragraph></td></tr><tr><td colspan="5"><paragraph><sup>f </sup>All patients received premedication.</paragraph></td></tr><tr><td colspan="5" styleCode=" Botrule"><paragraph><sup>†</sup> Severe events are defined as at least Grade III toxicity.</paragraph></td></tr></tbody></table>
adverse reactions table <table><caption>TABLE 16: FREQUENCY<sup>a</sup> OF IMPORTANT ADVERSE EVENTS IN THE AIDS-RELATED KAPOSI’S SARCOMA STUDIES</caption><col/><col/><col/><col/><tbody><tr><td styleCode=" Toprule"/><td styleCode=" Toprule"/><td align="center" colspan="2" styleCode=" Botrule"><paragraph>Percent of Patients</paragraph></td></tr><tr><td styleCode=" Botrule"/><td styleCode=" Botrule"/><td align="center" styleCode=" Botrule"><paragraph>Study CA139-174 Paclitaxel 135/3<sup>b</sup> q 3 wk (n = 29)</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>Study CA139-281 Paclitaxel 100/3<sup>b</sup> q 2 wk (n = 56)</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Bone Marrow</content></content></paragraph></td><td/><td/><td/></tr><tr><td><paragraph> —Neutropenia</paragraph></td><td><paragraph>< 2000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>100</paragraph></td><td align="center"><paragraph>95</paragraph></td></tr><tr><td/><td><paragraph>< 500/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>76 </paragraph></td><td align="center"><paragraph>35</paragraph></td></tr><tr><td><paragraph> —Thrombocytopenia </paragraph></td><td><paragraph>< 100,000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>52 </paragraph></td><td align="center"><paragraph>27</paragraph></td></tr><tr><td/><td><paragraph>< 50,000/mm<sup>3</sup></paragraph></td><td align="center"><paragraph>17 </paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td><paragraph> —Anemia</paragraph></td><td><paragraph>< 11 g/dL</paragraph></td><td align="center"><paragraph>86</paragraph></td><td align="center"><paragraph>73</paragraph></td></tr><tr><td/><td><paragraph>< 8 g/dL</paragraph></td><td align="center"><paragraph>34</paragraph></td><td align="center"><paragraph>25</paragraph></td></tr><tr><td><paragraph> —Febrile Neutropenia</paragraph></td><td/><td align="center"><paragraph>55 </paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Opportunistic Infection</content></content></paragraph></td><td/></tr><tr><td><paragraph> —Any</paragraph></td><td/><td align="center"><paragraph>76</paragraph></td><td align="center"><paragraph>54</paragraph></td></tr><tr><td><paragraph> —Cytomegalovirus</paragraph></td><td/><td align="center"><paragraph>45</paragraph></td><td align="center"><paragraph>27</paragraph></td></tr><tr><td><paragraph> —Herpes Simplex</paragraph></td><td/><td align="center"><paragraph>38 </paragraph></td><td align="center"><paragraph>11</paragraph></td></tr><tr><td><paragraph> —<content styleCode="italics">Pneumocystis carinii</content></paragraph></td><td/><td align="center"><paragraph>14</paragraph></td><td align="center"><paragraph>21</paragraph></td></tr><tr><td><paragraph> —<content styleCode="italics">M. avium intracellulare</content></paragraph></td><td/><td align="center"><paragraph>24</paragraph></td><td align="center"><paragraph>4</paragraph></td></tr><tr><td colspan="2"><paragraph> —Candidiasis, esophageal</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td><paragraph> —Cryptosporidiosis</paragraph></td><td/><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>7</paragraph></td></tr><tr><td colspan="2"><paragraph> —Cryptococcal meningitis</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph> —Leukoencephalopathy</paragraph></td><td/><td align="center"><paragraph>—</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Hypersensitivity Reaction</content><sup>c</sup></content></paragraph></td><td/></tr><tr><td><paragraph> —All</paragraph></td><td/><td align="center"><paragraph>14 </paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Cardiovascular</content></content></paragraph></td><td/></tr><tr><td><paragraph> —Hypotension</paragraph></td><td/><td align="center"><paragraph>17</paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td><paragraph> —Bradycardia</paragraph></td><td/><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>—</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Peripheral Neuropathy</content></content></paragraph></td><td/></tr><tr><td><paragraph> —Any</paragraph></td><td/><td align="center"><paragraph>79</paragraph></td><td align="center"><paragraph>46</paragraph></td></tr><tr><td><paragraph> —Severe<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>10</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Myalgia/Arthralgia</content></content></paragraph></td><td/><td/><td/></tr><tr><td><paragraph> —Any</paragraph></td><td/><td align="center"><paragraph>93 </paragraph></td><td align="center"><paragraph>48</paragraph></td></tr><tr><td><paragraph> —Severe<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>14</paragraph></td><td align="center"><paragraph>16</paragraph></td></tr><tr><td><paragraph><content styleCode="bold">• <content styleCode="italics">Gastrointestinal</content></content></paragraph></td><td/><td/><td/></tr><tr><td><paragraph> —Nausea and Vomiting</paragraph></td><td/><td align="center"><paragraph>69</paragraph></td><td align="center"><paragraph>70</paragraph></td></tr><tr><td><paragraph> —Diarrhea</paragraph></td><td/><td align="center"><paragraph>90</paragraph></td><td align="center"><paragraph>73</paragraph></td></tr><tr><td><paragraph> —Mucositis</paragraph></td><td/><td align="center"><paragraph>45</paragraph></td><td align="center"><paragraph>20</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">• <content styleCode="italics">Renal (creatinine elevation)</content></content></paragraph></td><td/></tr><tr><td><paragraph> —Any</paragraph></td><td/><td align="center"><paragraph>34</paragraph></td><td align="center"><paragraph>18</paragraph></td></tr><tr><td><paragraph> —Severe<sup>†</sup></paragraph></td><td/><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td colspan="2" styleCode=" Botrule"><paragraph><content styleCode="bold">• <content styleCode="italics">Discontinuation for drug toxicity</content></content></paragraph></td><td align="center" styleCode=" Botrule"><paragraph>7</paragraph></td><td align="center" styleCode=" Botrule"><paragraph>16</paragraph></td></tr><tr><td colspan="4"><paragraph><sup>a</sup> Based on worst course analysis.</paragraph></td></tr><tr><td colspan="4"><paragraph><sup>b</sup> Paclitaxel dose in mg/m<sup>2</sup>/infusion duration in hours. </paragraph></td></tr><tr><td colspan="4"><paragraph><sup>c</sup> All patients received premedication.</paragraph></td></tr><tr><td colspan="4" styleCode=" Botrule"><paragraph><sup>†</sup> Severe events are defined as at least Grade III toxicity.</paragraph></td></tr></tbody></table>
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