FDA label b1aef238-5cd9-47cb-a83f-1f5eac49f013

WARNING: DIFFERENTIATION SYNDROME Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. ( 5.1 , 6.1 )

5 WARNINGS AND PRECAUTIONS • Posterior reversible encephalopathy syndrome (PRES): Discontinue XOSPATA in patients who develop PRES. ( 2.3 , 5.2 , 6.1 ) • Prolonged QT Interval: Interrupt and reduce XOSPATA dosage in patients who have a QTcF >500 msec. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration. ( 2.3 , 5.3 , 12.2 , 6.1 ) • Pancreatitis: Interrupt and reduce the dose in patients who develop pancreatitis. ( 2.3 , 5.4 ) • Embryo-Fetal Toxicity: XOSPATA can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Differentiation Syndrome Of 319 patients treated with XOSPATA in the clinical trials, 3% experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms and other clinical findings of differentiation syndrome in patients treated with XOSPATA included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Some cases had concomitant acute febrile neutrophilic dermatosis. Differentiation syndrome occurred as early as 1 day and up to 82 days after XOSPATA initiation and has been observed with or without concomitant leukocytosis. Of the 11 patients who experienced differentiation syndrome, 9 (82%) recovered after treatment or after dose interruption of XOSPATA. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. Taper corticosteroids after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt XOSPATA until signs and symptoms are no longer severe [see Dosage and Administration ( 2.3 )] . 5.2 Posterior Reversible Encephalopathy Syndrome Of 319 patients treated with XOSPATA in the clinical trials, 1% experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES [see Dosage and Administration ( 2.3 ) and Adverse Reactions ( 6.1 )] . 5.3 Prolonged QT Interval XOSPATA has been associated with prolonged cardiac ventricular repolarization (QT interval). Of the 317 patients with a post-baseline QTc measurement on treatment with XOSPATA in the clinical trial, 1% were found to have a QTc interval greater than 500 msec and 7% of patients had an increase from baseline QTc greater than 60 msec. Perform electrocardiogram (ECG) prior to initiation of treatment with gilteritinib, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and reduce XOSPATA dosage in patients who have a QTcF >500 msec [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 ) and Clinical Pharmacology ( 12.2 )] . Hypokalemia or hypomagnesemia may increase the QT prolongation risk. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration. 5.4 Pancreatitis Of 319 patients treated with XOSPATA in the clinical trials, 4% experienced pancreatitis. Evaluate patients who develop signs and symptoms of pancreatitis. Interrupt and reduce the dose of XOSPATA in patients who develop pancreatitis [see Dosage and Administration ( 2.3 )] . 5.5 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, XOSPATA can cause embryo-fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused embryo-fetal lethality, suppressed fetal growth and teratogenicity at maternal exposures (AUC 24 ) approximately 0.4 times the AUC 24 in patients receiving the recommended dose. Advise females of reproductive potential to use effective contraception during treatment with XOSPATA and for 6 months after the last dose of XOSPATA. Advise males with female partners of reproductive potential to use effective contraception during treatment with XOSPATA and for 4 months after the last dose of XOSPATA. Pregnant women, patients becoming pregnant while receiving XOSPATA or male patients with pregnant female partners should be apprised of the potential risk to the fetus [see Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.1 )] .

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Differentiation syndrome [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Posterior reversible encephalopathy syndrome [see Warnings and Precautions ( 5.2 )] • Prolonged QT interval [see Warnings and Precautions ( 5.3 )] • Pancreatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥20%) are transaminase increased, myalgia/arthralgia, fatigue/malaise, fever, mucositis, edema, rash, noninfectious diarrhea, dyspnea, nausea, cough, constipation, eye disorders, headache, dizziness, hypotension, vomiting, and renal impairment. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 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 profile of XOSPATA is based on 319 patients with relapsed or refractory AML treated with gilteritinib 120 mg daily in three clinical trials. The median duration of exposure to XOSPATA was 3.6 months (range 0.1 to 43.4 months). Fatal adverse reactions occurred in 2% of patients receiving XOSPATA. These included cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%). Of the 319 patients, 91 (29%) required a dose interruption due to an adverse reaction; the most common adverse reactions leading to dose interruption were aspartate aminotransferase increased (6%), alanine aminotransferase increased (6%) and fever (4%). Twenty patients (6%) required a dose reduction due to an adverse reaction. Twenty-two (7%) discontinued XOSPATA treatment permanently due to an adverse reaction. The most common (>1%) adverse reactions leading to discontinuation were aspartate aminotransferase increased (2%) and alanine aminotransferase increased (2%). Overall, for the 319 patients, the most frequent (≥10%) all-grade nonhematological adverse reactions reported in patients were transaminase increased (51%), myalgia/arthralgia (50%), fatigue/malaise (44%), fever (41%), mucositis (41%), edema (40%), rash (36%), noninfectious diarrhea (35%), dyspnea (35%), nausea (30%), cough (28%), constipation (28%), eye disorders (25%), headache (24%), dizziness (22%), hypotension (22%), vomiting (21%), renal impairment (21%), abdominal pain (18%), neuropathy (18%), insomnia (15%) and dysgeusia (11%). The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%). Shifts to grades 3-4 nonhematologic laboratory abnormalities included phosphate decreased 42/309 (14%), alanine aminotransferase increased 41/317 (13%), sodium decreased 37/314 (12%), aspartate aminotransferase increased 33/317 (10%), calcium decreased 19/312 (6%), creatine kinase increased 20/317 (6%), triglycerides increased 18/310 (6%), creatinine increased 10/316 (3%), and alkaline phosphatase increased 5/317 (2%). Adverse reactions reported in the first 30 days of therapy on the ADMIRAL Study [see Clinical Studies ( 14 )] are shown in Tables 2 and 3 , according to whether patients were preselected for high intensity or low intensity chemotherapy. Table 2: Adverse Reactions Reported in ≥10% (Any Grade) or ≥5% (Grade 3-5) Grade 3-5 includes serious, life-threatening and fatal adverse reactions of Patients with Relapsed or Refractory AML in the Pre-selected High Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL Trial Adverse Reaction Any Grade n (%) Grade ≥3 n (%) XOSPATA (120 mg daily) n=149 Chemotherapy n=68 XOSPATA (120 mg daily) n=149 Chemotherapy n=68 Musculoskeletal and connective tissue disorders Myalgia/arthralgia Grouped terms: arthralgia, back pain, bone pain, flank pain, limb discomfort, medial tibial stress syndrome, myalgia, muscle twitching, musculoskeletal discomfort, musculoskeletal pain, muscle spasms, neck pain, non-cardiac chest pain, pain and pain in extremity 56 (38) 20 (29) 1 (1) 3 (4) Investigations Transaminase increased Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hepatoxicity, liver function test increased and transaminases increased 46 (31) 11 (16) 15 (10) 5 (7) General disorders and administration site conditions Fatigue/malaise Grouped terms: asthenia, fatigue, lethargy and malaise 36 (24) 9 (13) 1 (1) 2 (3) Fever 25 (17) 21 (31) 2 (1) 4 (6) Edema Grouped terms: edema, edema peripheral, face edema, fluid overload, generalized edema, hypervolemia, localized edema, periorbital edema and swelling face 20 (13) 13 (19) 0 0 Gastrointestinal disorders Constipation 29 (20) 10 (15) 0 0 Mucositis Grouped terms: aphthous ulcer, colitis, enteritis, esophageal pain, gingival pain, large intestinal ulcer, laryngeal inflammation, lip blister, lip ulceration, mouth hemorrhage, mouth ulceration, mucosal inflammation, oral discomfort, oral pain, oropharyngeal pain, proctalgia, stomatitis, swollen tongue, tongue discomfort and tongue ulceration 18 (12) 30 (44) 0 5 (7) Nausea 23 (15) 26 (38) 0 0 Abdominal pain Grouped terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and gastrointestinal pain 16 (11) 16 (24) 0 0 Blood and lymphatic system disorder Febrile neutropenia 26 (17) 30 (44) 26 (17) 30 (44) Skin and subcutaneous tissue disorders Rash Grouped terms: acne, dermatitis bullous, dermatitis contact, drug eruption, eczema asteatotic, erythema, hyperkeratosis, lichenoid keratosis, palmar-plantar erythrodysesthesia syndrome, rash, rash maculo-papular, rash papular, skin exfoliation, skin lesion and skin hyperpigmentation 23 (15) 21 (31) 1 (1) 2 (3) Respiratory, thoracic and mediastinal disorders Dyspnea Grouped terms: acute respiratory distress syndrome, dyspnea, dyspnea exertional, hypoxia, pulmonary edema, respiratory failure, tachypnea and wheezing 20 (13) 9 (13) 1 (1) 6 (9) Cough 18 (12) 5 (7) 1 (1) 0 Nervous system disorders Neuropathy Grouped terms: hyperesthesia, hypoesthesia, neuralgia, neuropathy peripheral, peripheral sensory neuropathy and paresthesia 19 (13) 0 0 0 Dizziness Grouped terms: coordination abnormal and dizziness 17 (11) 2 (3) 0 0 Headache 17 (11) 12 (18) 0 0 Table 3: Adverse Reactions Reported in ≥10% (Any Grade) or ≥5% (Grade 3-5) Grade 3-5 includes serious, life-threatening and fatal adverse reactions of Patients with Relapsed or Refractory AML in the Pre-selected Low Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL Trial Adverse Reaction Any Grade n (%) Grade ≥3 n (%) XOSPATA (120 mg daily) n=97 Chemotherapy n=41 XOSPATA (120 mg daily) n=97 Chemotherapy n=41 Investigations Transaminase increased Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased and transaminases increased 35 (36) 6 (15) 9 (9) 1 (2) Blood and lymphatic system disorder Febrile neutropenia 26 (27) 5 (12) 25 (26) 5 (12) Musculoskeletal and connective tissue disorders Myalgia/arthralgia Grouped terms: arthralgia, arthritis, back pain, limb discomfort, myalgia, muscle contracture, muscle spasms, myositis, non-cardiac chest pain, pain, pain in extremity and polyarthritis 21 (22) 7 (17) 2 (2) 0 General disorders and administration site conditions Fatigue/malaise Grouped terms: asthenia, fatigue and malaise 20 (21) 9 (22) 4 (4) 1 (2) Edema Grouped terms: edema, face edema, localized edema, edema peripheral, peripheral swelling, periorbital edema, scrotal edema and swelling face 19 (20) 5 (12) 1 (1) 0 Fever 11 (11) 7 (17) 0 0 Gastrointestinal disorders Mucositis Grouped terms: colitis, mouth hemorrhage, mouth ulceration, mucosal inflammation, oropharyngeal pain, proctalgia, stomatitis, tongue discomfort and tongue ulceration 19 (20) 7 (17) 1 (1) 1 (2) Constipation 13 (13) 5 (12) 1 (1) 0 Diarrhea 12 (12) 2 (5) 0 0 Nausea 10 (10) 7 (17) 0 0 Respiratory, thoracic and mediastinal disorders Dyspnea Grouped terms: acute respiratory failure, dyspnea, hypoxia and respiratory failure 11 (11) 2 (5) 3 (3) 2 (5) Skin and subcutaneous tissue disorders Rash Grouped terms: dermatitis acneiform, dermatitis bullous, dermatitis exfoliative, erythema, rash, rash maculo-papular, rash papular, rosacea and skin ulcer 10 (10) 2 (5) 2 (2) 0 Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged (9%), hypersensitivity* (8%), pancreatitis* (5%), cardiac failure* (4%), pericardial effusion (4%), acute febrile neutrophilic dermatosis (3%), differentiation syndrome (3%), pericarditis/myocarditis* (2%), large intestine perforation (1%), and posterior reversible encephalopathy syndrome (1%). *Grouped terms: cardiac failure (cardiac failure, cardiac failure congestive, cardiomegaly, cardiomyopathy, chronic left ventricular failure, and ejection fraction decreased), hypersensitivity (anaphylactic reaction, angioedema, dermatitis allergic, drug hypersensitivity, erythema multiforme, hypersensitivity, and urticaria), pancreatitis (amylase increased, lipase increased, pancreatitis, pancreatitis acute), pericarditis/myocarditis (myocarditis, pericardial hemorrhage, pericardial rub, and pericarditis). Selected post-baseline laboratory values that were observed in patients with relapsed or refractory AML are shown in Table 4 . Table 4: Shifts to Grade 3-4 Laboratory Abnormalities in Patients with Relapsed or Refractory AML by Pre-selected High Intensity and Low Intensity Chemotherapy in the First 30 Days of the ADMIRAL Trial Pre-selected High Intensity Chemotherapy Subgroup Pre-selected Low Intensity Chemotherapy Subgroup XOSPATA (120 mg daily) Chemotherapy XOSPATA (120 mg daily) Chemotherapy Alanine aminotransferase increased 7/149 (5%) 1/66 (2%) 7/95 (7%) 1/41 (2%) Alkaline phosphatase increased 1/149 (1%) 0 0 0 Aspartate aminotransferase increased 8/149 (5%) 2/65 (3%) 5/95 (5%) 0 Calcium decreased 2/149 (1%) 3/65 (5%) 3/94 (3%) 0 Creatine kinase increased 1/149 (1%) 0 1/95 (1%) 0 Phosphatase decreased 4/144 (3%) 6/65 (9%) 4/93 (4%) 3/38 (8%) Sodium decreased 7/148 (5%) 5/65 (8%) 6/93 (6%) 2/41 (5%) Triglycerides increased 1/146 (1%) 0 2/94 (2%) 0

<table ID="_Ref11056930" width="99%"><caption>Table 2: Adverse Reactions Reported in &#x2265;10% (Any Grade) or &#x2265;5% (Grade 3-5)<footnote ID="_Ref11052180">Grade 3-5 includes serious, life-threatening and fatal adverse reactions</footnote> of Patients with Relapsed or Refractory AML in the Pre-selected High Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL Trial</caption><col width="21%"/><col width="21%"/><col width="21%"/><col width="21%"/><col width="15%"/><tbody><tr><td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Any Grade</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Grade &#x2265;3</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">XOSPATA</content></paragraph><paragraph><content styleCode="bold">(120 mg daily)</content></paragraph><paragraph><content styleCode="bold">n=149</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Chemotherapy</content> <content styleCode="bold">n=68</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">XOSPATA</content></paragraph><paragraph><content styleCode="bold">(120 mg daily)</content></paragraph><paragraph><content styleCode="bold">n=149</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Chemotherapy</content> <content styleCode="bold">n=68</content></paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Myalgia/arthralgia<footnote ID="_Ref11052512">Grouped terms: arthralgia, back pain, bone pain, flank pain, limb discomfort, medial tibial stress syndrome, myalgia, muscle twitching, musculoskeletal discomfort, musculoskeletal pain, muscle spasms, neck pain, non-cardiac chest pain, pain and pain in extremity</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>56 (38)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>20 (29)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>3 (4)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Investigations</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Transaminase increased<footnote ID="_Ref11052550">Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hepatoxicity, liver function test increased and transaminases increased</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>46 (31)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>11 (16)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>15 (10)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (7)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">General disorders and administration site conditions</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Fatigue/malaise<footnote ID="_Ref11052608">Grouped terms: asthenia, fatigue, lethargy and malaise</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>36 (24)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>9 (13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Fever</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>25 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>21 (31)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>4 (6)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Edema<footnote ID="_Ref11052631">Grouped terms: edema, edema peripheral, face edema, fluid overload, generalized edema, hypervolemia, localized edema, periorbital edema and swelling face</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>20 (13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>13 (19)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Gastrointestinal disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>29 (20)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>10 (15)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Mucositis<footnote ID="_Ref11052675">Grouped terms: aphthous ulcer, colitis, enteritis, esophageal pain, gingival pain, large intestinal ulcer, laryngeal inflammation, lip blister, lip ulceration, mouth hemorrhage, mouth ulceration, mucosal inflammation, oral discomfort, oral pain, oropharyngeal pain, proctalgia, stomatitis, swollen tongue, tongue discomfort and tongue ulceration</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>18 (12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>30 (44)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (7)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>23 (15)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>26 (38)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Abdominal pain<footnote ID="_Ref11052695">Grouped terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and gastrointestinal pain</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>16 (11)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>16 (24)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Blood and lymphatic system disorder</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Febrile neutropenia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>26 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>30 (44)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>26 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>30 (44)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Skin and subcutaneous tissue disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Rash<footnote ID="_Ref11052733">Grouped terms: acne, dermatitis bullous, dermatitis contact, drug eruption, eczema asteatotic, erythema, hyperkeratosis, lichenoid keratosis, palmar-plantar erythrodysesthesia syndrome, rash, rash maculo-papular, rash papular, skin exfoliation, skin lesion and skin hyperpigmentation</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>23 (15)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>21 (31)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (3)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dyspnea<footnote ID="_Ref11052749">Grouped terms: acute respiratory distress syndrome, dyspnea, dyspnea exertional, hypoxia, pulmonary edema, respiratory failure, tachypnea and wheezing</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>20 (13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>9 (13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>6 (9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Cough</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>18 (12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Nervous system disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Neuropathy<footnote ID="_Ref11052764">Grouped terms: hyperesthesia, hypoesthesia, neuralgia, neuropathy peripheral, peripheral sensory neuropathy and paresthesia</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>19 (13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dizziness<footnote ID="_Ref11052770">Grouped terms: coordination abnormal and dizziness</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>17 (11)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Headache</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>17 (11)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>12 (18)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>0</paragraph></td></tr></tbody></table>

<table ID="_Ref11056944" width="99.84%"><caption>Table 3: Adverse Reactions Reported in &#x2265;10% (Any Grade) or &#x2265;5% (Grade 3-5)<footnote ID="_Ref11053124">Grade 3-5 includes serious, life-threatening and fatal adverse reactions</footnote> of Patients with Relapsed or Refractory AML in the Pre-selected Low Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL Trial</caption><col width="21%"/><col width="21%"/><col width="21%"/><col width="21%"/><col width="15%"/><tbody><tr><td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Any Grade</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Grade &#x2265;3</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">XOSPATA</content></paragraph><paragraph><content styleCode="bold">(120 mg daily)</content></paragraph><paragraph><content styleCode="bold">n=97</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Chemotherapy</content> <content styleCode="bold">n=41</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">XOSPATA</content></paragraph><paragraph><content styleCode="bold">(120 mg daily)</content></paragraph><paragraph><content styleCode="bold">n=97</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Chemotherapy</content> <content styleCode="bold">n=41</content></paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Investigations</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Transaminase increased<footnote ID="_Ref11053257">Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased and transaminases increased</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>35 (36)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>6 (15)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>9 (9)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (2)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Blood and lymphatic system disorder</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Febrile neutropenia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>26 (27)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>25 (26)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (12)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Myalgia/arthralgia<footnote ID="_Ref11053389">Grouped terms: arthralgia, arthritis, back pain, limb discomfort, myalgia, muscle contracture, muscle spasms, myositis, non-cardiac chest pain, pain, pain in extremity and polyarthritis</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>21 (22)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">General disorders and administration site conditions</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Fatigue/malaise<footnote ID="_Ref11053406">Grouped terms: asthenia, fatigue and malaise</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>20 (21)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>9 (22)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>4 (4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (2)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Edema<footnote ID="_Ref11053431">Grouped terms: edema, face edema, localized edema, edema peripheral, peripheral swelling, periorbital edema, scrotal edema and swelling face</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>19 (20)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Fever</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>11 (11)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Gastrointestinal disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Mucositis<footnote ID="_Ref11053443">Grouped terms: colitis, mouth hemorrhage, mouth ulceration, mucosal inflammation, oropharyngeal pain, proctalgia, stomatitis, tongue discomfort and tongue ulceration</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>19 (20)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (2)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>13 (13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Diarrhea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>12 (12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>10 (10)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7 (17)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dyspnea<footnote ID="_Ref11053453">Grouped terms: acute respiratory failure, dyspnea, hypoxia and respiratory failure</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>11 (11)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>3 (3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2 (5)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Skin and subcutaneous tissue disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Rash<footnote ID="_Ref11053460">Grouped terms: dermatitis acneiform, dermatitis bullous, dermatitis exfoliative, erythema, rash, rash maculo-papular, rash papular, rosacea and skin ulcer</footnote></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>10 (10)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>2 (5)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>2 (2)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>0</paragraph></td></tr></tbody></table>

<table ID="_Ref11056985" width="100%"><caption>Table 4: Shifts to Grade 3-4 Laboratory Abnormalities in Patients with Relapsed or Refractory AML by Pre-selected High Intensity and Low Intensity Chemotherapy in the First 30 Days of the ADMIRAL Trial</caption><col width="21%"/><col width="21%"/><col width="21%"/><col width="21%"/><col width="15%"/><tbody><tr><td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"/><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Pre-selected High Intensity Chemotherapy Subgroup</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Pre-selected Low Intensity Chemotherapy Subgroup</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">XOSPATA</content></paragraph><paragraph><content styleCode="bold">(120 mg daily)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Chemotherapy</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">XOSPATA</content></paragraph><paragraph><content styleCode="bold">(120 mg daily)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Chemotherapy</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Alanine aminotransferase increased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7/149 (5%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1/66 (2%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7/95 (7%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1/41 (2%)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Alkaline phosphatase increased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1/149 (1%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Aspartate aminotransferase increased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>8/149 (5%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2/65 (3%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5/95 (5%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Calcium decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2/149 (1%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>3/65 (5%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>3/94 (3%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Creatine kinase increased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1/149 (1%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1/95 (1%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Phosphatase decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>4/144 (3%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>6/65 (9%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>4/93 (4%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>3/38 (8%)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Sodium decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>7/148 (5%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5/65 (8%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>6/93 (6%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>2/41 (5%)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Triglycerides increased</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>1/146 (1%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>2/94 (2%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>0</paragraph></td></tr></tbody></table>