DOCEFREZ (Page 3 of 8)

5.4 Hypersensitivity Reactions

Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions. Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients premedicated with 3 days of corticosteroids. Severe hypersensitivity reactions require immediate discontinuation of the DOCEFREZ infusion and aggressive therapy. Patients with a history of severe hypersensitivity reactions should not be rechallenged with DOCEFREZ.Hypersensitivity reactions may occur within a few minutes following initiation of a DOCEFREZ infusion. If minor reactions such as flushing or localized skin reactions occur, interruption of therapy is not required. All patients should be premedicated with an oral corticosteroid prior to the initiation of the infusion of DOCEFREZ [see Dosage and Administration (2.6)].

5.5 Fluid Retention

Severe fluid retention has been reported following docetaxel therapy. Patients should be premedicated with oral corticosteroids prior to each DOCEFREZ administration to reduce the incidence and severity of fluid retention [see Dosage and Administration (2.6)]. Patients with pre-existing effusions should be closely monitored from the first dose for the possible exacerbation of the effusions.
When fluid retention occurs, peripheral edema usually starts in the lower extremities and may become generalized with a median weight gain of 2 kg.
Among 92 breast cancer patients premedicated with 3-day corticosteroids, moderate fluid retention occurred in 27.2% and severe fluid retention in 6.5%. The median cumulative dose to onset of moderate or severe fluid retention was 819 mg/m2. Nine of 92 patients (9.8%) of patients discontinued treatment due to fluid retention: 4 patients discontinued with severe fluid retention; the remaining 5 had mild or moderate fluid retention. The median cumulative dose to treatment discontinuation due to fluid retention was 1,021 mg/m2.Fluid retention was completely, but sometimes slowly, reversible with a median of 16 weeks from the last infusion of docetaxel to resolution (range: 0 to 42+ weeks). Patients developing peripheral edema may be treated with standard measures, e.g., salt restriction, oral diuretic(s).

5.6 Acute Myeloid Leukemia

Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use in adjuvant therapy for breast cancer. The risk of delayed myelodysplasia or myeloid leukemia requires hematological follow-up.

5.7 Cutaneous Reactions

Localized erythema of the extremities with edema followed by desquamation has been observed. In case of severe skin toxicity, an adjustment in dosage is recommended [see Dosage and Administration (2.7)]. The discontinuation rate due to skin toxicity was 1.6% (15/965) for metastatic breast cancer patients. Among 92 breast cancer patients premedicated with 3-day corticosteroids, there were no cases of severe skin toxicity reported and no patient discontinued docetaxel due to skin toxicity.

5.8 Neurologic Reactions

Severe neurosensory symptoms (e.g.paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued [see Dosage and Administration (2.7)]. Patients who experienced neurotoxicity in clinical trials and for whom follow-up information on the complete resolution of the event was available had spontaneous reversal of symptoms with a median of 9 weeks from onset (range: 0 to 106 weeks). Severe peripheral motor neuropathy mainly manifested as distal extremity weakness occurred in 4.4% (42/965).

5.9 Eye Disorders

Cystoid macular edema (CME) has been reported in patients treated with DOCEFREZ. Patients with impaired vision should undergo a prompt and comprehensive ophthalmologic examination. If CME is diagnosed, DOCEFREZ treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.

5.10 Alcohol Content

Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol content. The alcohol content in a dose of Docetaxel Injection may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in Docetaxel Injection on the ability to drive or use machines immediately after the infusion.

Each administration of Docetaxel Injection at 100 mg/m2 delivers 1.425 g/m2 of ethanol. For a patient with a BSA of 2.0 m2 , this would deliver 2.85 grams of ethanol [see Description (11)]. Other docetaxel products may have a different amount of alcohol.

5.11 Asthenia

Severe asthenia has been reported in 14.9% (144/965) of metastatic breast cancer patients but has led to treatment discontinuation in only 1.8%. Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease.

5.12 Use in Pregnancy

DOCEFREZ can cause fetal harm when administered to a pregnant woman. Docetaxel caused embryofetal toxicities including intrauterine mortality when administered to pregnant rats and rabbits during the period of organogenesis. Embryofetal effects in animals occurred at doses as low as 1/50 and 1/300 the recommended human dose on a body surface area basis.There are no adequate and well-controlled studies in pregnant women using DOCEFREZ. If DOCEFREZ 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 during therapy with DOCEFREZ [see Use in Specific Populations (8.1)].

6 ADVERSE REACTIONS

The most serious adverse reactions from docetaxel are:

  • Toxic Deaths [see Boxed Warning, Warnings and Precautions (5.1)]
  • Hepatotoxicity [see Boxed Warning, Warnings and Precautions (5.2)]
  • Neutropenia [see Boxed Warning, Warnings and Precautions (5.3)]
  • Hypersensitivity [see Boxed Warning, Warnings and Precautions (5.4)]
  • Fluid Retention [see Boxed Warning, Warnings and Precautions (5.5)]

The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication.
Adverse reactions are described for docetaxel according to indication. 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.
Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established.

6.1 Clinical Trial Experience

Breast Cancer
Monotherapy with docetaxel for locally advanced or metastatic breast cancer after failure of prior chemotherapy


Docetaxel 100 mg/m2 : Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received docetaxel administered at 100 mg/m2 as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function tests; and an additional 61 patients with various tumor types who had abnormal liver function tests at baseline. These reactions were described using COSTART terms and were considered possibly or probably related to docetaxel. At least 95% of these patients did not receive hematopoietic support. The safety profile is generally similar in patients receiving docetaxel for the treatment of breast cancer and in patients with other tumor types (See Table 2).

Table 2 — Summary of Adverse Reactions in Patients Receiving Docetaxel at 100 mg/m2
*
Normal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
Elevated Baseline LFTs: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
Febrile Neutropenia: ANC grade 4 with fever >38oC with intravenous antibiotics and/or hospitalization
Adverse Reaction All Tumor Types Normal LFTs * n=2045 % All Tumor Types Elevated LFTs n=61 % Breast Cancer Normal LFTs * n=965 %
Hematologic Neutropenia<2000 cells/mm3 <500 cells/mm3 Leukopenia<4000 cells/mm3 <1000 cells/mm3 Thrombocytopenia<100,000 cells/mm3 Anemia<11 g/dL<8 g/dL Febrile Neutropenia 96759632890911 9688984725923126 99869944994812
Septic Death Non-Septic Death 21 57 11
Infections AnySevere 226 3316 226
Fever in Absence of Infection AnySevere 312 418 352
Hypersensitivity Reactions Regardless of Premedication AnySevere With 3-day PremedicationAnySevere 214n=92152 2010n=3330 183n=92152
Fluid Retention Regardless of PremedicationAnySevereWith 3-day PremedicationAnySevere 477n=92647 398n=36733 609n=92647
Neurosensory AnySevere 494 340 586
Cutaneous AnySevere 485 5410 475
Nail Changes AnySevere 313 235 414
Gastrointestinal NauseaVomitingDiarrheaSevere 3922395 3823335 4223436
Stomatitis AnySevere 426 4913 527
Alopecia 76 62 74
Asthenia AnySevere 6213 5325 6615
Myalgia AnySevere 192 162 212
Arthralgia 9 7 8
Infusion Site Reactions 4 3 4


Hematologic Reactions

Reversible marrow suppression was the major dose-limiting toxicity of docetaxel [see Warnings and Precautions (5.3)]. The median time to nadir was 7 days, while the median duration of severe neutropenia (<500 cells/mm3) was 7 days. Among 2045 patients with solid tumors and normal baseline LFTs, severe neutropenia occurred in 75.4% and lasted for more than 7 days in 2.9% of cycles.

Febrile neutropenia (<500 cells/mm3 with fever > 38°C with intravenous antibiotics and/or hospitalization) occurred in 11% of patients with solid tumors, in 12.3% of patients with metastatic breast cancer, and in 9.8% of 92 breast cancer patients premedicated with 3-day corticosteroids.

Severe infectious episodes occurred in 6.1% of patients with solid tumors, in 6.4% of patients with metastatic breast cancer, and in 5.4% of 92 breast cancer patients premedicated with 3-day corticosteroids.

Thrombocytopenia (<100,000 cells/mm3) associated with fatal gastrointestinal hemorrhage has been reported.

Hypersensitivity Reactions

Severe hypersensitivity reactions have been reported [see Boxed Warning, Warnings and Precautions (5.4)]. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, or chills, have been reported and resolved after discontinuing the infusion and instituting appropriate therapy.

Fluid Retention

Fluid retention can occur with the use of DOCEFREZ [see Boxed Warning, Dosage and Administration (2.6), Warnings and Precautions (5.5)].

Cutaneous Reactions

Severe skin toxicity is discussed elsewhere in the label [see Warnings and Precautions (5.7)]. Reversible cutaneous reactions characterized by a rash including localized eruptions, mainly on the feet and/or hands, but also on the arms, face, or thorax, usually associated with pruritus, have been observed. Eruptions generally occurred within 1 week after docetaxel infusion, recovered before the next infusion, and were not disabling.

Severe nail disorders were characterized by hypo- or hyperpigmentation, and occasionally by onycholysis (in 0.8% of patients with solid tumors) and pain.

Neurologic Reactions

Neurologic reactions are discussed elsewhere in the label [ see Warnings and Precautions (5.8)].

Gastrointestinal Reactions

Nausea, vomiting, and diarrhea were generally mild to moderate. Severe reactions occurred in 3-5% of patients with solid tumors and to a similar extent among metastatic breast cancer patients. The incidence of severe reactions was 1% or less for the 92 breast cancer patients premedicated with 3-day corticosteroids.

Severe stomatitis occurred in 5.5% of patients with solid tumors, in 7.4% of patients with metastatic breast cancer, and in 1.1% of the 92 breast cancer patients premedicated with 3-day corticosteroids.

Cardiovascular Reactions

Hypotension occurred in 2.8% of patients with solid tumors; 1.2% required treatment. Clinically meaningful events such as heart failure, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, and hypertension occurred rarely. Seven of 86 patients (8.1%) of metastatic breast cancer patients receiving docetaxel 100 mg/m2 in a randomized trial and who had serial left ventricular ejection fractions assessed developed deterioration of LVEF by ≥ 10% associated with a drop below the institutional lower limit of normal.

Infusion Site Reactions

Infusion site reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or swelling of the vein.

Hepatic Reactions

In patients with normal LFTs at baseline, bilirubin values greater than the ULN occurred in 8.9% of patients. Increases in AST or ALT > 1.5 times the ULN, or alkaline phosphatase > 2.5 times ULN, were observed in 18.9% and 7.3% of patients, respectively. While on docetaxel, increases in AST and/or ALT > 1.5 times ULN concomitant with alkaline phosphatase > 2.5 times ULN occurred in 4.3% of patients with normal LFTs at baseline. Whether these changes were related to the drug or underlying disease has not been established.

Hematologic and Other Toxicity: Relation to dose and baseline liver chemistry abnormalities

Hematologic and other toxicity is increased at higher doses and in patients with elevated baseline liver function tests (LFTs). In the following tables, adverse drug reactions are compared for three populations: 730 patients with normal LFTs given docetaxel at 100 mg/m2 in the randomized and single arm studies of metastatic breast cancer after failure of previous chemotherapy; 18 patients in these studies who had abnormal baseline LFTs (defined as AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN); and 174 patients in Japanese studies given docetaxel at 60 mg/m2 who had normal LFTs (see Tables 3 and 4).

Table 3 — Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m2 with Normal or Elevated Liver Function Tests or 60 mg/m2 with Normal Liver Function Tests
*
Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN.
Elevated Baseline LFTs: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN.
Incidence of infection requiring hospitalization and/or intravenous antibiotics was 8.5% (n=62) among the 730 patients with normal LFTs at baseline; 7 patients had concurrent grade 3 neutropenia, and 46 patients had grade 4 neutropenia.
§
Febrile Neutropenia: For 100 mg/m2 , ANC grade 4 and fever > 38°C with intravenous antibiotics and/or hospitalization; for 60 mg/m2 , ANC grade 3/4 and fever > 38.1°C.
Adverse Reaction Docetaxel 100 mg/m2 Docetaxel 60 mg/m2
Normal LFTs * n=730 % Elevated LFTs n=18 % NormalLFTs * n=174 %
Neutropenia Any <2000 cells/mm3 Grade 4 <500 cells/mm3 9884 10094 9575
Thrombocytopenia Any <100,000 cells/mm3 Grade 4 <20,000 cells/mm3 111 4417 141
Anemia <11 g/dL 95 94 65
Infection AnyGrade 3 and 4 237 3933 10
Febrile Neutropenia §By PatientBy Course 122 339 00
Septic Death 2 6 1
Non-Septic Death 1 11 0
Table 4 — Non-Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m2 with Normal or Elevated Liver Function Tests or 60 mg/m2 with Normal Liver Function Tests
*
Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN..
Elevated Baseline Liver Function: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN..
Fluid Retention includes (by COSTART): edema (peripheral, localized, generalized, lymphedema, pulmonary edema, and edema otherwise not specified) and effusion (pleural, pericardial, and ascites); no premedication given with the 60 mg/m2 dose
§
NA = not available
Adverse Reaction Docetaxel 100 mg/m2 Docetaxel 60 mg/m2
Normal LFTs * n=730 % Elevated LFTs n=18 % Normal LFTs * n=174 %
Acute Hypersensitivity Reaction Regardless of Premedication AnySevere 131 60 10
Fluid Retention Regardless of Premedication AnySevere 568 6117 130
Neurosensory AnySevere 576 500 200
Myalgia 23 33 3
Cutaneous AnySevere 455 6117 310
Asthenia AnySevere 6517 4422 660
Diarrhea AnySevere 426 2811 NA §
Stomatitis AnySevere 538 6739 191

In the three-arm monotherapy trial, TAX313, which compared docetaxel 60 mg/m2 , 75 mg/m2 and 100 mg/m2 in advanced breast cancer, grade 3/4 or severe adverse reactions occurred in 49.0% of patients treated with docetaxel 60 mg/m2 compared to 55.3% and 65.9% treated with 75 mg/m2 and 100 mg/m2 respectively. Discontinuation due to adverse reactions was reported in 5.3% of patients treated with 60 mg/m2 vs. 6.9% and 16.5% for patients treated at 75 mg/m2 and 100 mg/m2 respectively. Deaths within 30 days of last treatment occurred in 4.0% of patients treated with 60 mg/m2 compared to 5.3% and 1.6% for patients treated at 75 mg/m2 and 100 mg/m2 respectively.
The following adverse reactions were associated with increasing docetaxel doses: fluid retention (26%, 38%, and 46% at 60 mg/m2 , 75 mg/m2 , and 100 mg/m2 respectively), thrombocytopenia (7%, 11%, and 12% respectively), neutropenia (92%, 94%, and 97% respectively), febrile neutropenia (5%, 7%, and 14% respectively), treatment-related grade 3/4 infection (2%, 3%, and 7% respectively) and anemia (87%, 94%, and 97% respectively).
Lung Cancer
Monotherapy with docetaxel for unresectable, locally advanced or metastatic NSCLC previously treated with platinum-based chemotherapyDocetaxel 75 mg/m2: Treatment emergent adverse drug reactions are shown in Table 5. Included in this table are safety data for a total of 176 patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who were treated in two randomized, controlled trials. These reactions were described using NCI Common Toxicity Criteria regardless of relationship to study treatment, except for the hematologic toxicities or where otherwise noted.

Table 5 — Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy *
*
Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
Febrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization.
Not Applicable;
§
Not Done
COSTART term and grading system
Adverse Reaction Docetaxel 75 mg/m2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 %
Neutropenia AnyGrade 3/4 8465 1412 8357
Leukopenia AnyGrade 3/4 8449 60 8943
Thrombocytopenia AnyGrade 3/4 83 00 82
Anemia AnyGrade 3/4 919 5512 9114
Febrile Neutropenia 6 NA 1
Infection AnyGrade 3/4 3410 296 309
Treatment Related Mortality 3 NA 3
Hypersensitivity Reactions AnyGrade 3/4 63 00 10
Fluid Retention AnySevere 343 ND § 233
Neurosensory AnyGrade 3/4 232 146 295
Neuromotor AnyGrade 3/4 165 86 103
Skin AnyGrade 3/4 201 62 171
Gastrointestinal NauseaAnyGrade 3/4VomitingAnyGrade 3/4DiarrheaAnyGrade 3/4 345223233 31427260 318226124
Alopecia 56 35 50
Asthenia AnySevere 5318 5739 5423
Stomatitis AnyGrade 3/4 262 60 81
Pulmonary AnyGrade 3/4 4121 4929 4519
Nail Disorder AnySevere 111 00 20
Myalgia AnySevere 60 00 30
Arthralgia AnySevere 30 20 21
Taste Perversion AnySevere 61 00 00

Combination therapy with docetaxel in chemotherapy-naïve advanced unresectable or metastatic NSCLC

Table 6 presents safety data from two arms of an open label, randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted.

Table 6 — Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy- Naïve Advanced Non-Small Cell Lung Cancer Patients Receiving Docetaxel in Combination with Cisplatin
*
Replaces NCI term “Allergy
COSTART term and grading system.
Adverse Reaction Docetaxel 75 mg/m2 + Cisplatin 75 mg/m2 n=406 % Vinorelbine 25 mg/m2 + Cisplatin 100 mg/m2 n=396 %
Neutropenia Any Grade 3/4 9174 9078
Febrile Neutropenia 5 5
Thrombocytopenia Any Grade 3/4 153 154
Anemia 89 94
Any
Grade 3/4 7 25
Infection 35 37
Any
Grade 3/4 8 8
Fever in absence of infection 33 29
Any
Grade 3/4 < 1 1
Hypersensitivity Reaction * 12 4
Any
Grade 3/4 3 < 1
Fluid Retention 54 42
Any
All severe or life-threatening events 2 2
Pleural effusion
Any 23 22
All severe or life-threatening events 2 2
Peripheral edema
Any 34 18
All severe or life-threatening events <1 <1
Weight gain
Any 15 9
All severe or life-threatening events <1 <1
Neurosensory
Any 47 42
Grade 3/4 4 4
Neuromotor
Any 19 17
Grade 3/4 3 6
Skin
Any 16 14
Grade 3/4 <1 1
Nausea
Any 72 76
Grade 3/4 10 17
Vomiting
Any 55 61
Grade 3/4 8 16
Diarrhea
Any 47 25
Grade 3/4 7 3
Anorexia
Any 42 40
All severe or life-threatening events 5 5
Stomatitis
Any 24 21
Grade 3/4 2 1
Alopecia
Any 75 42
Grade 3 <1 0
Asthenia
Any 74 75
All severe or life-threatening events 12 14
Nail Disorder
Any 14 <1
All severe events <1 0
Myalgia
Any 18 12
All severe events <1 <1

Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the docetaxel+cisplatin arm and 37 patients (9.3%) in the vinorelbine+cisplatin arm. Deaths within 30 days of last study treatment attributed to study drug occurred in 9 patients (2.2%) in the docetaxel+cisplatin arm and 8 patients (2%) in the vinorelbine+cisplatin arm. The second comparison in the study, vinorelbine+cisplatin versus docetaxel+carboplatin (which did not demonstrate a superior survival associated with DOCEFREZ, [see Clinical Studies (14.3)]) demonstrated a higher incidence of thrombocytopenia, diarrhea, fluid retention, hypersensitivity reactions, skin toxicity, alopecia and nail changes on the docetaxel+carboplatin arm, while a higher incidence of anemia, neurosensory toxicity, nausea, vomiting, anorexia and asthenia was observed on the vinorelbine+cisplatin arm.

Prostate Cancer
Combination therapy with docetaxel in patients with prostate cancerThe following data are based on the experience of 332 patients, who were treated with docetaxel 75 mg/m² every 3 weeks in combination with prednisone 5 mg orally twice daily (see Table 7).

Table 7 — Clinically Important Treatment Emergent Adverse Reactions (Regardless of Relationship) in Patients with Prostate Cancer who Received Docetaxel in Combination with Prednisone (TAX327)
*
Related to treatment.
Docetaxel 75 mg/m2 every 3 weeks + prednisone 5 mg twice daily n=332 % Mitoxantrone 12 mg/m2 every 3 weeks + prednisone 5 mg twice daily n=335 %
Adverse Reaction Any Grade 3/4 Any Grade 3/4
Anemia 67 5 58 2
Neutropenia 41 32 48 22
Thrombocytopenia 3 1 8 1
Febrile neutropenia 3 N/A 2 N/A
Infection 32 6 20 4
Epistaxis 6 0 2 0
Allergic Reactions 8 1 1 0
Fluid Retention *Weight Gain *Peripheral Edema * 24818 100 532 000
Neuropathy Sensory 30 2 7 0
Neuropathy Motor 7 2 3 1
Rash/Desquamation 6 0 3 1
Alopecia 65 N/A 13 N/A
Nail Changes 30 0 8 0
Nausea 41 3 36 2
Diarrhea 32 2 10 1
Stomatitis/Pharyngitis 20 1 8 0
Taste Disturbance 18 0 7 0
Vomiting 17 2 14 2
Anorexia 17 1 14 0
Cough 12 0 8 0
Dyspnea 15 3 9 1
Cardiac left ventricular function 10 0 22 1
Fatigue 53 5 35 5
Myalgia 15 0 13 1
Tearing 10 1 2 0
Arthralgia 8 1 5 1

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