FDA label b19c6845-843f-4f22-ad61-dc1ff1270d81

5 WARNINGS AND PRECAUTIONS Infusion Reactions: Premedicate with an intravenous corticosteroid (as appropriate), an oral analgesic, and an oral or intravenous antihistamine. Monitor patients closely during infusions. Interrupt infusion if infusion reactions occur. (2.3, 2.4, 5.1) Cytopenias: Monitor blood counts at regular intervals for neutropenia and thrombocytopenia. (5.2) Progressive Multifocal Leukoencephalopathy (PML): Monitor neurologic function and discontinue ARZERRA if PML is suspected. (5.3) Hepatitis B Infection and Reactivation: Screen high-risk patients. Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis. (5.4) 5.1 Infusion Reactions ARZERRA can cause serious infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac ischemia/infarction, back pain, abdominal pain, pyrexia, rash, urticaria, and angioedema. Infusion reactions occur more frequently with the first 2 infusions [see Adverse Reactions (6.1)] . Premedicate with acetaminophen, an antihistamine, and a corticosteroid [see Dosage and Administration (2.1, 2.4)] . Interrupt infusion for infusion reactions of any severity. Institute medical management for severe infusion reactions including angina or other signs and symptoms of myocardial ischemia [see Dosage and Administration (2.3)] . In a study of patients with moderate to severe chronic obstructive pulmonary disease, an indication for which ARZERRA is not approved, 2 of 5 patients developed Grade 3 bronchospasm during infusion. 5.2 Cytopenias Prolonged (≥1 week) severe neutropenia and thrombocytopenia can occur with ARZERRA. Monitor complete blood counts (CBC) and platelet counts at regular intervals during therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. 5.3 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML), including fatal PML, can occur with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. Discontinue ARZERRA if PML is suspected, and initiate evaluation for PML including consultation with a neurologist, brain MRI, and lumbar puncture. 5.4 Hepatitis B Infection and Reactivation Fulminant and fatal hepatitis B virus (HBV) infection can occur in patients newly exposed to HBV following treatment with ARZERRA. In addition, hepatitis B reactivation, including fulminant hepatitis and death, occurs with other monoclonal antibodies directed against CD20. Screen patients at high risk of HBV infection before initiation of ARZERRA. Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV infection during treatment with ARZERRA and for 6 to 12 months following the last infusion of ARZERRA. Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis, and institute appropriate treatment. Insufficient data exist regarding the safety of administration of ARZERRA in patients with active hepatitis. 5.5 Intestinal Obstruction Obstruction of the small intestine can occur in patients receiving ARZERRA. Perform a diagnostic evaluation if obstruction is suspected. 5.6 Immunizations The safety of immunization with live viral vaccines during or following administration of ARZERRA has not been studied. Do not administer live viral vaccines to patients who have recently received ARZERRA. The ability to generate an immune response to any vaccine following administration of ARZERRA has not been studied.

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions [see Warnings and Precautions (5.1)] Cytopenias [see Warnings and Precautions (5.2)] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3)] Hepatitis B Reactivation [see Warnings and Precautions (5.4)] Intestinal Obstruction [see Warnings and Precautions (5.5)] The most common adverse reactions (≥10%) in Study 1 were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions in Study 1 were infections (including pneumonia and sepsis), neutropenia, and pyrexia. Infections were the most common adverse reactions leading to drug discontinuation in Study 1. Most common adverse reactions (≥10%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. (6) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 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 safety of monotherapy with ARZERRA was evaluated in 181 patients with relapsed or refractory CLL in 2 open-label, non-randomized, single-arm studies. In these studies, ARZERRA was administered at 2,000 mg beginning with the second dose for 11 doses (Study 1 [n = 154]) or 3 doses (Study 2 [n = 27]). The data described in Table 2 and other sections below are derived from 154 patients in Study 1. All patients received 2,000 mg weekly from the second dose onward. Ninety percent of patients received at least 8 infusions of ARZERRA and 55% received all 12 infusions. The median age was 63 years (range: 41 to 86 years), 72% were male, and 97% were White. Table 2. Incidence of All Adverse Reactions Occurring in ≥5% of Patients in Study 1 and in the Fludarabine- and Alemtuzumab-Refractory Subset of Study 1 (MedDRA 9.0) Body System/Adverse Event Total Population (n = 154) Fludarabine- and Alemtuzumab-Refractory (n = 59) All Grades % Grade ≥3 % All Grades % Grade ≥3 % Infections and infestations Pneumonia a 23 14 25 15 Upper respiratory tract infection 11 0 3 0 Bronchitis 11 <1 19 2 Sepsis b 8 8 10 10 Nasopharyngitis 8 0 8 0 Herpes zoster 6 1 7 2 Sinusitis 5 2 3 2 Blood and lymphatic system disorders Anemia 16 5 17 8 Psychiatric disorders Insomnia 7 0 10 0 Nervous system disorders Headache 6 0 7 0 Cardiovascular disorders Hypertension 5 0 8 0 Hypotension 5 0 3 0 Tachycardia 5 <1 7 2 Respiratory, thoracic, and mediastinal disorders Cough 19 0 19 0 Dyspnea 14 2 19 5 Gastrointestinal disorders Diarrhea 18 0 19 0 Nausea 11 0 12 0 Skin and subcutaneous tissue disorders Rash c 14 <1 17 2 Urticaria 8 0 5 0 Hyperhidrosis 5 0 5 0 Musculoskeletal and connective tissue disorders Back pain 8 1 12 2 Muscle spasms 5 0 3 0 General disorders and administration site conditions Pyrexia 20 3 25 5 Fatigue 15 0 15 0 Edema peripheral 9 <1 8 2 Chills 8 0 10 0 a Pneumonia includes pneumonia, lung infection, lobar pneumonia, and bronchopneumonia. b Sepsis includes sepsis, neutropenic sepsis, bacteremia, and septic shock. c Rash includes rash, rash macular, and rash vesicular. Infusion Reactions: Infusion reactions occurred in 44% of patients on the day of the first infusion (300 mg), 29% on the day of the second infusion (2,000 mg), and less frequently during subsequent infusions. Infections: A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced ≥Grade 3 infections, of which 19 (12%) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%. Neutropenia: Of 108 patients with normal neutrophil counts at baseline, 45 (42%) developed ≥Grade 3 neutropenia. Nineteen (18%) developed Grade 4 neutropenia. Some patients experienced new onset Grade 4 neutropenia >2 weeks in duration. 6.2 Immunogenicity There is a potential for immunogenicity with therapeutic proteins such as ofatumumab. Serum samples from patients with CLL in Study 1 were tested by enzyme-linked immunosorbent assay (ELISA) for anti-ofatumumab antibodies during and after the 24-week treatment period. Results were negative in 46 patients after the 8 th infusion and in 33 patients after the 12 th infusion. Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to ARZERRA with the incidence of antibodies to other products may be misleading.

<table border="single" width="636.000" ID="id_1cd6573b-d1ab-4a7a-b8ed-198d2e8c9dc4"> <caption ID="id_cd666c87-7576-41f3-a77b-38dc2908322f">Table 2. Incidence of All Adverse Reactions Occurring in &#x2265;5% of Patients in Study 1 and in the Fludarabine- and Alemtuzumab-Refractory Subset of Study 1 (MedDRA 9.0)</caption> <col width="39.8%"/> <col width="16.4%"/> <col width="12.9%"/> <col width="16.4%"/> <col width="14.6%"/> <tbody> <tr ID="id_b414fe4a-0222-4b35-8c19-52744efb3752"> <td align="center" valign="bottom" rowspan="2" styleCode="Botrule Toprule Rrule Lrule">Body System/Adverse Event</td> <td align="center" valign="bottom" colspan="2" styleCode="Botrule Rrule"> <paragraph>Total Population</paragraph>(n = 154)</td> <td align="center" valign="bottom" colspan="2" styleCode="Botrule Rrule"> <paragraph>Fludarabine- and Alemtuzumab-Refractory</paragraph>(n = 59)</td> </tr> <tr ID="id_87d638fa-60b8-454f-9b23-1b3b9a99b2f1"> <td align="center" valign="bottom" styleCode="Lrule Botrule Rrule"> <paragraph>All Grades</paragraph>%</td> <td align="center" valign="bottom" styleCode="Botrule Rrule"> <paragraph>Grade &#x2265;3</paragraph>%</td> <td align="center" valign="bottom" styleCode="Botrule Rrule"> <paragraph>All Grades</paragraph>%</td> <td align="center" valign="bottom" styleCode="Botrule Rrule"> <paragraph>Grade &#x2265;3</paragraph>%</td> </tr> <tr ID="id_6f9e35a6-7d74-4951-9052-1ba0d6929942"> <td align="left" valign="top" styleCode="Lrule Rrule">Infections and infestations</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_aeeeaa0c-7bc4-45da-a077-e473b30c71f7"> <td align="left" valign="top" styleCode="Lrule Rrule"> Pneumonia^a </td> <td align="center" valign="top" styleCode="Rrule">23</td> <td align="center" valign="top" styleCode="Rrule">14</td> <td align="center" valign="top" styleCode="Rrule">25</td> <td align="center" valign="top" styleCode="Rrule">15</td> </tr> <tr ID="id_9019caa8-de32-4a8a-921c-0323e62d5238"> <td align="left" valign="top" styleCode="Lrule Rrule"> Upper respiratory tract infection</td> <td align="center" valign="top" styleCode="Rrule">11</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">3</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_bb6eaf3e-2f16-4153-94ec-e3a987cc27df"> <td align="left" valign="top" styleCode="Lrule Rrule"> Bronchitis</td> <td align="center" valign="top" styleCode="Rrule">11</td> <td align="center" valign="top" styleCode="Rrule">&lt;1</td> <td align="center" valign="top" styleCode="Rrule">19</td> <td align="center" valign="top" styleCode="Rrule">2</td> </tr> <tr ID="id_db075e6a-a4ff-4619-a7d7-ea21f1b764a6"> <td align="left" valign="top" styleCode="Lrule Rrule"> Sepsis^b </td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">10</td> <td align="center" valign="top" styleCode="Rrule">10</td> </tr> <tr ID="id_72fe9186-077d-4703-8592-a3a7b6b1f55e"> <td align="left" valign="top" styleCode="Lrule Rrule"> Nasopharyngitis</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_aff41226-2c67-4af1-95aa-7148c0423f43"> <td align="left" valign="top" styleCode="Lrule Rrule"> Herpes zoster</td> <td align="center" valign="top" styleCode="Rrule">6</td> <td align="center" valign="top" styleCode="Rrule">1</td> <td align="center" valign="top" styleCode="Rrule">7</td> <td align="center" valign="top" styleCode="Rrule">2</td> </tr> <tr ID="id_1d6448bb-aab1-43af-9421-0633d8ee1f90"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Sinusitis</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</td> <td align="center" valign="top" styleCode="Botrule Rrule">2</td> <td align="center" valign="top" styleCode="Botrule Rrule">3</td> <td align="center" valign="top" styleCode="Botrule Rrule">2</td> </tr> <tr ID="id_4eb0a423-582a-4abb-b845-6f80f2cb46f5"> <td align="left" valign="top" styleCode="Lrule Rrule">Blood and lymphatic system disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_b11089ad-7549-45fc-ab1b-e766be4bba2a"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Anemia</td> <td align="center" valign="top" styleCode="Botrule Rrule">16</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</td> <td align="center" valign="top" styleCode="Botrule Rrule">17</td> <td align="center" valign="top" styleCode="Botrule Rrule">8</td> </tr> <tr ID="id_9dc7ee14-aaa4-4673-b8f8-aada9b7da0af"> <td align="left" valign="top" styleCode="Lrule Rrule">Psychiatric disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_ae634cfd-c08f-4030-99de-7a7c4fc1aabb"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Insomnia</td> <td align="center" valign="top" styleCode="Botrule Rrule">7</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> <td align="center" valign="top" styleCode="Botrule Rrule">10</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_c633e698-63b6-48aa-8fd7-9de76da387d5"> <td align="left" valign="top" styleCode="Lrule Rrule">Nervous system disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_055a3ea3-35fc-4070-84d7-c131716b77cc"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Headache</td> <td align="center" valign="top" styleCode="Botrule Rrule">6</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 ID="id_7dd91b37-4a8d-4fe2-abdf-bb6504c8746d"> <td align="left" valign="top" styleCode="Lrule Rrule">Cardiovascular disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_94ccd1d3-4487-43c2-88a8-8c6cfb63e2b3"> <td align="left" valign="top" styleCode="Lrule Rrule"> Hypertension</td> <td align="center" valign="top" styleCode="Rrule">5</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_460c9f16-f2fe-495d-b723-cd988921f16b"> <td align="left" valign="top" styleCode="Lrule Rrule"> Hypotension</td> <td align="center" valign="top" styleCode="Rrule">5</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">3</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_b31532eb-efac-489e-be9d-f19e7a84ffe6"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Tachycardia</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</td> <td align="center" valign="top" styleCode="Botrule Rrule">&lt;1</td> <td align="center" valign="top" styleCode="Botrule Rrule">7</td> <td align="center" valign="top" styleCode="Botrule Rrule">2</td> </tr> <tr ID="id_b1fc09d6-e6fa-4aee-af72-ef7bfbfe6281"> <td align="left" valign="top" styleCode="Lrule Rrule">Respiratory, thoracic, and mediastinal disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_94934904-e0fd-4db1-826b-3b2a07fe3c50"> <td align="left" valign="top" styleCode="Lrule Rrule"> Cough</td> <td align="center" valign="top" styleCode="Rrule">19</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">19</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_05ae06f5-0b5f-474b-836b-79169d64925d"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dyspnea</td> <td align="center" valign="top" styleCode="Botrule Rrule">14</td> <td align="center" valign="top" styleCode="Botrule Rrule">2</td> <td align="center" valign="top" styleCode="Botrule Rrule">19</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</td> </tr> <tr ID="id_03bb45a0-d660-4a44-9808-5316a4f768d9"> <td align="left" valign="top" styleCode="Lrule Rrule">Gastrointestinal disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_bd607daa-f11e-4e73-a068-333040353f5a"> <td align="left" valign="top" styleCode="Lrule Rrule"> Diarrhea</td> <td align="center" valign="top" styleCode="Rrule">18</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">19</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_b2246db8-2ad2-457d-9f66-4a2947034d64"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Nausea</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">12</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_78fd8a78-7423-4ffd-9824-90b2506544dd"> <td align="left" valign="top" styleCode="Lrule Rrule">Skin and subcutaneous tissue disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_a6fd87bb-ae81-41a4-91a4-9393342f95d4"> <td align="left" valign="top" styleCode="Lrule Rrule"> Rash^c </td> <td align="center" valign="top" styleCode="Rrule">14</td> <td align="center" valign="top" styleCode="Rrule">&lt;1</td> <td align="center" valign="top" styleCode="Rrule">17</td> <td align="center" valign="top" styleCode="Rrule">2</td> </tr> <tr ID="id_0bb1e0f1-47b9-43df-977d-6a1a4d787de1"> <td align="left" valign="top" styleCode="Lrule Rrule"> Urticaria</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">5</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_e3a31be9-fd5f-4848-ae4a-1b9d12deab37"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Hyperhidrosis</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_1e5ae7e0-afc5-409b-9fbd-75c7ffe30500"> <td align="left" valign="top" styleCode="Lrule Rrule">Musculoskeletal and connective tissue disorders</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_ed7e5dc0-307f-4867-9452-971833a64064"> <td align="left" valign="top" styleCode="Lrule Rrule"> Back pain</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">1</td> <td align="center" valign="top" styleCode="Rrule">12</td> <td align="center" valign="top" styleCode="Rrule">2</td> </tr> <tr ID="id_a915dfd1-70ae-4725-a1cf-800ecf8a25e8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Muscle spasms</td> <td align="center" valign="top" styleCode="Botrule Rrule">5</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 ID="id_f8885b4e-ba99-476f-8c26-7aa3b4d35c61"> <td align="left" valign="top" styleCode="Lrule Rrule">General disorders and administration site conditions</td> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> <td align="center" valign="top" styleCode="Rrule"/> </tr> <tr ID="id_f9feeddb-8260-4a41-91d3-e500be3612b9"> <td align="left" valign="top" styleCode="Lrule Rrule"> Pyrexia</td> <td align="center" valign="top" styleCode="Rrule">20</td> <td align="center" valign="top" styleCode="Rrule">3</td> <td align="center" valign="top" styleCode="Rrule">25</td> <td align="center" valign="top" styleCode="Rrule">5</td> </tr> <tr ID="id_c35c5a92-7ddb-4f20-9db6-67ccdcf25a7a"> <td align="left" valign="top" styleCode="Lrule Rrule"> Fatigue</td> <td align="center" valign="top" styleCode="Rrule">15</td> <td align="center" valign="top" styleCode="Rrule">0</td> <td align="center" valign="top" styleCode="Rrule">15</td> <td align="center" valign="top" styleCode="Rrule">0</td> </tr> <tr ID="id_4abc5a79-329d-4b9a-8d98-57d2e15778e3"> <td align="left" valign="top" styleCode="Lrule Rrule"> Edema peripheral</td> <td align="center" valign="top" styleCode="Rrule">9</td> <td align="center" valign="top" styleCode="Rrule">&lt;1</td> <td align="center" valign="top" styleCode="Rrule">8</td> <td align="center" valign="top" styleCode="Rrule">2</td> </tr> <tr ID="id_b1103667-b498-4ada-9318-efe000e09dc3"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Chills</td> <td align="center" valign="top" styleCode="Botrule Rrule">8</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> <td align="center" valign="top" styleCode="Botrule Rrule">10</td> <td align="center" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_870e7d1c-27cd-44ce-b31a-cc2e9fc21162"> <td align="left" valign="top" colspan="5" styleCode="Lrule Rrule"> ^a Pneumonia includes pneumonia, lung infection, lobar pneumonia, and bronchopneumonia.</td> </tr> <tr ID="id_ee1a7ba3-44e2-4a05-a594-3ffb91254106"> <td align="left" valign="top" colspan="5" styleCode="Lrule Rrule"> ^b Sepsis includes sepsis, neutropenic sepsis, bacteremia, and septic shock.</td> </tr> <tr ID="id_8d6ba272-f98b-4f4b-82b4-cb3457fb8057"> <td align="left" valign="top" colspan="5" styleCode="Lrule Botrule Rrule"> ^c Rash includes rash, rash macular, and rash vesicular.</td> </tr> </tbody> </table>