FDA label d0840b8c-54c5-4d78-b543-cea91eb65733

5 WARNINGS AND PRECAUTIONS • Myelosuppression: Delay or reduce dose. Restart treatment based on ANC and platelet count recovery. ( 2.1 ) Complications of myelosuppression may lead to death. ( 5.1 ) • Infections: Monitor for fever and other signs of infection and treat promptly. ( 5.2 ) • Anaphylaxis and Infusion Reactions: Severe and anaphylactic reactions have occurred; monitor clinically and discontinue TREANDA. Pre-medicate in subsequent cycles for milder reactions. ( 5.3 ) • Tumor Lysis Syndrome: Acute renal failure and death; anticipate and use supportive measures. ( 5.4 ) • Skin Reactions: Discontinue for severe skin reactions. Cases of SJS and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. ( 5.5 ) • Other Malignancies: Pre-malignant and malignant diseases have been reported. ( 5.6 ) • Extravasation: Assure good venous access and monitor infusion site during and after administration. ( 5.7 ) • Embryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving TREANDA. ( 5.8 , 8.1 ) 5.1 Myelosuppression TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies (see Table 4). Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV). In the event of treatment-related myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially. Hematologic nadirs were observed predominantly in the third week of therapy. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the ANC should be ≥ 1 x 10 9 /L and the platelet count should be ≥ 75 x 10 9 /L. [See Dosage and Administration ( 2.1 ) and ( 2.2 )] 5.2 Infections Infection, including pneumonia, sepsis, septic shock, and death have occurred in adult and pediatric patients in clinical trials and in postmarketing reports. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections. Advise patients with myelosuppression following TREANDA treatment to contact a physician if they have symptoms or signs of infection. 5.3 Anaphylaxis and Infusion Reactions Infusion reactions to TREANDA have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Patients who experience Grade 3 or worse allergic-type reactions should not be rechallenged. Consider measures to prevent severe reactions, including antihistamines, antipyretics and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions. Discontinue TREANDA for patients with Grade 4 infusion reactions. Consider discontinuation for Grade 3 infusions reactions as clinically appropriate considering individual benefits, risks, and supportive care. 5.4 Tumor Lysis Syndrome Tumor lysis syndrome associated with TREANDA treatment has occurred in patients in clinical trials and in postmarketing reports. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of TREANDA therapy. However, there may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly [see Warnings and Precautions ( 5.5 )] . 5.5 Skin Reactions Skin reactions have been reported with TREANDA treatment in clinical trials and postmarketing safety reports, including rash, toxic skin reactions and bullous exanthema. Some events occurred when TREANDA was given in combination with other anticancer agents. In a study of TREANDA (90 mg/m 2 ) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab (see rituximab package insert). Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. The relationship to TREANDA cannot be determined. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue TREANDA. 5.6 Other Malignancies There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma. The association with TREANDA therapy has not been determined. 5.7 Extravasation Injury TREANDA extravasations have been reported in post marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. 5.8 Embryo-fetal Toxicity TREANDA can cause fetal harm when administered to a pregnant woman. Single intraperitoneal doses of bendamustine in mice and rats administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations, and decreased fetal body weights. [See Use in Specific Populations ( 8.1 )]

6 ADVERSE REACTIONS The following serious adverse reactions have been associated with TREANDA in clinical trials and are discussed in greater detail in other sections of the label. • Myelosuppression [See Warnings and Precautions ( 5.1 )] • Infections [See Warnings and Precautions ( 5.2 )] • Anaphylaxis and Infusion Reactions [See Warnings and Precautions ( 5.3 )] • Tumor Lysis Syndrome [See Warnings and Precautions ( 5.4 )] • Skin Reactions [See Warnings and Precautions ( 5.5 )] • Other Malignancies [See Warnings and Precautions ( 5.6 )] • Extravasation injury [See Warnings and Precautions (5.7)] The data described below reflect exposure to TREANDA in 329 patients who participated in an actively-controlled trial (N=153) for the treatment of CLL and two single-arm trials (N=176) for the treatment of indolent B-cell NHL. 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. • Most common non-hematologic adverse reactions for CLL (frequency ≥ 15%) are pyrexia, nausea, and vomiting. ( 6.1 ) • Most common non-hematologic adverse reactions for NHL (frequency ≥ 15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. ( 6.2 ) • Most common hematologic abnormalities for both indications (frequency ≥ 15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-800-896-5855 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience in CLL The data described below reflect exposure to TREANDA in 153 patients with CLL studied in an active-controlled, randomized trial. The population was 45-77 years of age, 63% male, 100% white, and were treatment naïve. All patients started the study at a dose of 100 mg/m 2 intravenously over 30 minutes on Days 1 and 2 every 28 days. Adverse reactions were reported according to NCI CTC v.2.0. Non-hematologic adverse reactions (any grade) in the TREANDA group that occurred with a frequency greater than 15% were pyrexia (24%), nausea (20%), and vomiting (16%). Other adverse reactions seen frequently in one or more studies included asthenia, fatigue, malaise, and weakness; dry mouth; somnolence; cough; constipation; headache; mucosal inflammation and stomatitis. Worsening hypertension was reported in 4 patients treated with TREANDA in the CLL trial and in none treated with chlorambucil. Three of these 4 adverse reactions were described as a hypertensive crisis and were managed with oral medications and resolved. The most frequent adverse reactions leading to study withdrawal for patients receiving TREANDA were hypersensitivity (2%) and pyrexia (1%). Table 1 contains the treatment emergent adverse reactions, regardless of attribution, that were reported in ≥ 5% of patients in either treatment group in the randomized CLL clinical study. Table 1: Non-Hematologic Adverse Reactions Occurring in Randomized CLL Clinical Study in at Least 5% of Patients Number (%) of patients TREANDA (N=153) Chlorambucil (N=143) System organ class Preferred term All Grades Grade 3/4 All Grades Grade 3/4 Total number of patients with at least 1 adverse reaction 121 (79) 52 (34) 96 (67) 25 (17) Gastrointestinal disorders Nausea 31 (20) 1 (<1) 21 (15) 1 (<1) Vomiting 24 (16) 1 (<1) 9 (6) 0 Diarrhea 14 (9) 2 (1) 5 (3) 0 General disorders and administration site conditions Pyrexia 36 (24) 6 (4) 8 (6) 2 (1) Fatigue 14 (9) 2 (1) 8 (6) 0 Asthenia 13 (8) 0 6 (4) 0 Chills 9 (6) 0 1 (<1) 0 Immune system disorders Hypersensitivity 7 (5) 2 (1) 3 (2) 0 Infections and infestations Nasopharyngitis 10 (7) 0 12 (8) 0 Infection 9 (6) 3 (2) 1 (<1) 1 (<1) Herpes simplex 5 (3) 0 7 (5) 0 Investigations Weight decreased 11 (7) 0 5 (3) 0 Metabolism and nutrition disorders Hyperuricemia 11 (7) 3 (2) 2 (1) 0 Respiratory, thoracic and mediastinal disorders Cough 6 (4) 1 (<1) 7 (5) 1 (<1) Skin and subcutaneous tissue disorders Rash 12 (8) 4 (3) 7 (5) 3 (2) Pruritus 8 (5) 0 2 (1) 0 The Grade 3 and 4 hematology laboratory test values by treatment group in the randomized CLL clinical study are described in Table 2. These findings confirm the myelosuppressive effects seen in patients treated with TREANDA. Red blood cell transfusions were administered to 20% of patients receiving TREANDA compared with 6% of patients receiving chlorambucil. Table 2: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA or Chlorambucil in the Randomized CLL Clinical Study TREANDA N=150 Chlorambucil N=141 Laboratory Abnormality All Grades n (%) Grade 3/4 n (%) All Grades n (%) Grade 3/4 n (%) Hemoglobin Decreased 134 (89) 20 (13) 115 (82) 12 (9) Platelets Decreased 116 (77) 16 (11) 110 (78) 14 (10) Leukocytes Decreased 92 (61) 42 (28) 26 (18) 4 (3) Lymphocytes Decreased 102 (68) 70 (47) 27 (19) 6 (4) Neutrophils Decreased 113 (75) 65 (43) 86 (61) 30 (21) In the CLL trial, 34% of patients had bilirubin elevations, some without associated significant elevations in AST and ALT. Grade 3 or 4 increased bilirubin occurred in 3% of patients. Increases in AST and ALT of Grade 3 or 4 were limited to 1% and 3% of patients, respectively. Patients treated with TREANDA may also have changes in their creatinine levels. If abnormalities are detected, monitoring of these parameters should be continued to ensure that further deterioration does not occur. 6.2 Clinical Trials Experience in NHL The data described below reflect exposure to TREANDA in 176 patients with indolent B-cell NHL treated in two single-arm studies. The population was 31-84 years of age, 60% male, and 40% female. The race distribution was 89% White, 7% Black, 3% Hispanic, 1% other, and <1% Asian. These patients received TREANDA at a dose of 120 mg/m 2 intravenously on Days 1 and 2 for up to eight 21-day cycles. The adverse reactions occurring in at least 5% of the NHL patients, regardless of severity, are shown in Table 3. The most common non-hematologic adverse reactions (≥30%) were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%). The most common non-hematologic Grade 3 or 4 adverse reactions (≥5%) were fatigue (11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration, each reported in 5% of patients. Table 3: Non-Hematologic Adverse Reactions Occurring in at Least 5% of NHL Patients Treated with TREANDA by System Organ Class and Preferred Term (N=176) System organ class Number (%) of patients* Preferred term All Grades Grade 3/4 Total number of patients with at least 1 adverse reaction 176 (100) 94 (53) Cardiac disorders Tachycardia 13 (7) 0 Gastrointestinal disorders Nausea 132 (75) 7 (4) Vomiting 71 (40) 5 (3) Diarrhea 65 (37) 6 (3) Constipation 51 (29) 1 (<1) Stomatitis 27 (15) 1 (<1) Abdominal pain 22 (13) 2 (1) Dyspepsia 20 (11) 0 Gastroesophageal reflux disease 18 (10) 0 Dry mouth 15 (9) 1 (<1) Abdominal pain upper 8 (5) 0 Abdominal distension 8 (5) 0 General disorders and administration site conditions Fatigue 101 (57) 19 (11) Pyrexia 59 (34) 3 (2) Chills 24 (14) 0 Edema peripheral 23 (13) 1 (<1) Asthenia 19 (11) 4 (2) Chest pain 11 (6) 1 (<1) Infusion site pain 11 (6) 0 Pain 10 (6) 0 Catheter site pain 8 (5) 0 Infections and infestations Herpes zoster 18 (10) 5 (3) Upper respiratory tract infection 18 (10) 0 Urinary tract infection 17 (10) 4 (2) Sinusitis 15 (9) 0 Pneumonia 14 (8) 9 (5) Febrile neutropenia 11 (6) 11 (6) Oral candidiasis 11 (6) 2 (1) Nasopharyngitis 11 (6) 0 Investigations Weight decreased 31 (18) 3 (2) Metabolism and nutrition disorders Anorexia 40 (23) 3 (2) Dehydration 24 (14) 8 (5) Decreased appetite 22 (13) 1 (<1) Hypokalemia 15 (9) 9 (5) Musculoskeletal and connective tissue disorders Back pain 25 (14) 5 (3) Arthralgia 11 (6) 0 Pain in extremity 8 (5) 2 (1) Bone pain 8 (5) 0 Nervous system disorders Headache 36 (21) 0 Dizziness 25 (14) 0 Dysgeusia 13 (7) 0 Psychiatric disorders Insomnia 23 (13) 0 Anxiety 14 (8) 1 (<1) Depression 10 (6) 0 Respiratory, thoracic and mediastinal disorders Cough 38 (22) 1 (<1) Dyspnea 28 (16) 3 (2) Pharyngolaryngeal pain 14 (8) 1 (<1) Wheezing 8 (5) 0 Nasal congestion 8 (5) 0 Skin and subcutaneous tissue disorders Rash 28 (16) 1 (<1) Pruritus 11 (6) 0 Dry skin 9 (5) 0 Night sweats 9 (5) 0 Hyperhidrosis 8 (5) 0 Vascular disorders Hypotension 10 (6) 2 (1) *Patients may have reported more than 1 adverse reaction. NOTE: Patients counted only once in each preferred term category and once in each system organ class category. Hematologic toxicities, based on laboratory values and CTC grade, in NHL patients treated in both single arm studies combined are described in Table 4. Clinically important chemistry laboratory values that were new or worsened from baseline and occurred in >1% of patients at Grade 3 or 4, in NHL patients treated in both single arm studies combined were hyperglycemia (3%), elevated creatinine (2%), hyponatremia (2%), and hypocalcemia (2%). Table 4: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA in the NHL Studies Percent of patients Hematology variable All Grades Grades 3/4 Lymphocytes Decreased 99 94 Leukocytes Decreased 94 56 Hemoglobin Decreased 88 11 Neutrophils Decreased 86 60 Platelets Decreased 86 25 In both studies, serious adverse reactions, regardless of causality, were reported in 37% of patients receiving TREANDA. The most common serious adverse reactions occurring in ≥5% of patients were febrile neutropenia and pneumonia. Other important serious adverse reactions reported in clinical trials and/or postmarketing experience were acute renal failure, cardiac failure, hypersensitivity, skin reactions, pulmonary fibrosis, and myelodysplastic syndrome. Serious drug-related adverse reactions reported in clinical trials included myelosuppression, infection, pneumonia, tumor lysis syndrome and infusion reactions [see Warnings and Precautions ( 5 )] . Adverse reactions occurring less frequently but possibly related to TREANDA treatment were hemolysis, dysgeusia/taste disorder, atypical pneumonia, sepsis, herpes zoster, erythema, dermatitis, and skin necrosis. 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of TREANDA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis; and injection or infusion site reactions including phlebitis, pruritus, irritation, pain, and swelling; pneumocystis jiroveci pneumonia and pneumonitis. Skin reactions including SJS and TEN have occurred when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. [See Warnings and Precautions ( 5.5 )]

<table ID="_RefID77ED69FBD485486DA864933E6A722DF2" width="100%"> <caption>Table 1: Non-Hematologic Adverse Reactions Occurring in Randomized CLL Clinical Study in at Least 5% of Patients </caption> <col width="52%"/> <col width="12%"/> <col width="11%"/> <col width="12%"/> <col width="11%"/> <tbody> <tr> <td styleCode="Botrule Lrule Toprule "> <paragraph> </paragraph> </td> <td align="center" colspan="4" styleCode="Botrule Toprule "> <paragraph> <content styleCode="bold">Number (%) of patients</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold"> </content> </paragraph> </td> <td colspan="2" styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">TREANDA</content> <content styleCode="bold">(N=153)</content> </paragraph> </td> <td colspan="2" styleCode="Botrule "> <paragraph> <content styleCode="bold">Chlorambucil</content> <content styleCode="bold">(N=143)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">System organ class </content> <content styleCode="bold"> Preferred term </content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">All Grades </content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Grade 3/4 </content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">All Grades </content> </paragraph> </td> <td styleCode="Botrule "> <paragraph> <content styleCode="bold">Grade 3/4 </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Total number of patients with at least 1 adverse reaction</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">121 (79)</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">52 (34)</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">96 (67)</content> </paragraph> </td> <td styleCode="Botrule "> <paragraph> <content styleCode="bold">25 (17)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Gastrointestinal disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Nausea</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>31 (20)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>21 (15)</paragraph> </td> <td styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Vomiting</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>24 (16)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>9 (6)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Diarrhea</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>14 (9)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>2 (1)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>5 (3)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">General disorders and administration site conditions</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pyrexia</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>36 (24)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>6 (4)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>8 (6)</paragraph> </td> <td styleCode="Botrule "> <paragraph>2 (1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Fatigue</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>14 (9)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>2 (1)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>8 (6)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Asthenia</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>13 (8)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>6 (4)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Chills</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>9 (6)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Immune system disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Hypersensitivity</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>7 (5)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>2 (1)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>3 (2)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Infections and infestations</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Nasopharyngitis</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>10 (7)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>12 (8)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Infection</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>9 (6)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>3 (2)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> <td styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Herpes simplex</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>5 (3)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>7 (5)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Investigations</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Weight decreased</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>11 (7)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>5 (3)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Metabolism and nutrition disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Hyperuricemia</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>11 (7)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>3 (2)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>2 (1)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Cough</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>6 (4)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>7 (5)</paragraph> </td> <td styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Skin and subcutaneous tissue disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> </paragraph> </td> <td styleCode="Botrule "> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Rash</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>12 (8)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>4 (3)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>7 (5)</paragraph> </td> <td styleCode="Botrule "> <paragraph>3 (2)</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule "> <paragraph> Pruritus</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>8 (5)</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>0</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>2 (1)</paragraph> </td> <td styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> </tbody> </table>

<table ID="_RefID1C74F0FE128242AEA48D5B6760B293C0" width="100%"> <caption>Table 2: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA or Chlorambucil in the Randomized CLL Clinical Study </caption> <col width="27%"/> <col width="13%"/> <col width="12%"/> <col width="13%"/> <col width="12%"/> <tbody> <tr> <td styleCode="Botrule Lrule Toprule "> <paragraph> <content styleCode="bold"> </content> </paragraph> </td> <td colspan="2" styleCode="Botrule Lrule Toprule "> <paragraph> <content styleCode="bold">TREANDA </content> <content styleCode="bold">N=150</content> </paragraph> </td> <td colspan="2" styleCode="Botrule Toprule "> <paragraph> <content styleCode="bold">Chlorambucil</content> <content styleCode="bold">N=141</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Laboratory Abnormality</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">All Grades</content> <content styleCode="bold">n (%)</content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Grade 3/4</content> <content styleCode="bold">n (%) </content> </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">All Grades</content> <content styleCode="bold">n (%)</content> </paragraph> </td> <td styleCode="Botrule "> <paragraph> <content styleCode="bold">Grade 3/4</content> <content styleCode="bold">n (%)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>Hemoglobin Decreased </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>134 (89)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>20 (13)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>115 (82)</paragraph> </td> <td styleCode="Botrule "> <paragraph>12 (9)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>Platelets Decreased </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>116 (77)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>16 (11)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>110 (78)</paragraph> </td> <td styleCode="Botrule "> <paragraph>14 (10)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>Leukocytes Decreased </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>92 (61)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>42 (28)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>26 (18)</paragraph> </td> <td styleCode="Botrule "> <paragraph>4 (3)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>Lymphocytes Decreased </paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>102 (68)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>70 (47)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>27 (19)</paragraph> </td> <td styleCode="Botrule "> <paragraph>6 (4)</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule "> <paragraph>Neutrophils Decreased </paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>113 (75)</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>65 (43)</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>86 (61)</paragraph> </td> <td styleCode="Botrule "> <paragraph>30 (21)</paragraph> </td> </tr> </tbody> </table>

<table ID="_RefID9E1908B15C524841B8A5A23306CFFFD5" width="100%"> <caption>Table 3: Non-Hematologic Adverse Reactions Occurring in at Least 5% of NHL Patients Treated with TREANDA by System Organ Class and Preferred Term (N=176) </caption> <col width="68%"/> <col width="16%"/> <col width="15%"/> <tbody> <tr> <td rowspan="1" styleCode="Botrule Lrule Toprule "> <paragraph> <content styleCode="bold">System organ class</content> </paragraph> </td> <td align="center" colspan="2" rowspan="1" styleCode="Botrule Toprule "> <paragraph> <content styleCode="bold">Number (%) of patients*</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold"> Preferred term</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">All Grades</content> </paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph> <content styleCode="bold">Grade 3/4</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> <content styleCode="bold">Total number of patients with at least 1 adverse reaction</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>176 (100)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>94 (53)</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Cardiac disorders</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Tachycardia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>13 (7)</paragraph> </td> <td align="center" rowspan="1" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Gastrointestinal disorders</content> </paragraph> </td> </tr> <tr> <td rowspan="1" styleCode="Lrule Botrule "> <paragraph> Nausea</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>132 (75)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>7 (4)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Vomiting</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>71 (40)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>5 (3)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Diarrhea</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>65 (37)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>6 (3)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Constipation</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>51 (29)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Stomatitis</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>27 (15)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Abdominal pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>22 (13)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>2 (1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dyspepsia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>20 (11)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Gastroesophageal reflux disease</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>18 (10)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dry mouth</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>15 (9)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Abdominal pain upper</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Abdominal distension</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">General disorders and administration site conditions</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Fatigue</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>101 (57)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>19 (11)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pyrexia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>59 (34)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>3 (2)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Chills</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>24 (14)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Edema peripheral</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>23 (13)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Asthenia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>19 (11)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>4 (2)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Chest pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Infusion site pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>10 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Catheter site pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Infections and infestations</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Herpes zoster</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>18 (10)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>5 (3)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Upper respiratory tract infection</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>18 (10)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Urinary tract infection</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>17 (10)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>4 (2)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Sinusitis</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>15 (9)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pneumonia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>14 (8)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>9 (5)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Febrile neutropenia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>11 (6)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Oral candidiasis</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>2 (1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Nasopharyngitis</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Investigations</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Weight decreased</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>31 (18)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>3 (2)</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Metabolism and nutrition disorders</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Anorexia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>40 (23)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>3 (2)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dehydration</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>24 (14)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>8 (5)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Decreased appetite</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>22 (13)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Hypokalemia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>15 (9)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>9 (5)</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Musculoskeletal and connective tissue disorders</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Back pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>25 (14)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>5 (3)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Arthralgia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pain in extremity</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>2 (1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Bone pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Nervous system disorders</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Headache</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>36 (21)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dizziness</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>25 (14)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dysgeusia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>13 (7)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Psychiatric disorders</content> </paragraph> </td> </tr> <tr> <td rowspan="1" styleCode="Lrule Botrule "> <paragraph> Insomnia</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>23 (13)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Anxiety</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>14 (8)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Depression</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>10 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Cough</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>38 (22)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dyspnea</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>28 (16)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>3 (2)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pharyngolaryngeal pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>14 (8)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Wheezing</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Nasal congestion</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Skin and subcutaneous tissue disorders</content> </paragraph> </td> </tr> <tr> <td rowspan="1" styleCode="Lrule Botrule "> <paragraph> Rash</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>28 (16)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>1 (&lt;1)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Pruritus</paragraph> </td> <td align="center" rowspan="1" styleCode="Lrule Botrule "> <paragraph>11 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Dry skin</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>9 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Night sweats</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>9 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Hyperhidrosis</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>8 (5)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph> <content styleCode="bold">Vascular disorders</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph> Hypotension</paragraph> </td> <td align="center" styleCode="Lrule Botrule "> <paragraph>10 (6)</paragraph> </td> <td align="center" styleCode="Botrule "> <paragraph>2 (1)</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Botrule "> <paragraph>*Patients may have reported more than 1 adverse reaction. <content styleCode="bold">NOTE:</content> Patients counted only once in each preferred term category and once in each system organ class category.</paragraph> </td> </tr> </tbody> </table>