FDA label eac12010-cb69-47a5-962e-6ae43c8f545c

WARNING: OCULAR TOXICITY BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes [see Warnings and Precautions ( 5.1 )] . Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )] . Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS [see Warnings and Precautions ( 5.2 )] . WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes. ( 5.1 ) • Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity. ( 2.3 , 5.1 ) • BLENREP is available only through a restricted program, called the BLENREP REMS. ( 5.2 )

5 WARNINGS AND PRECAUTIONS • Thrombocytopenia : Perform complete blood counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity. ( 2.3 , 5.3 ) • Infusion-Related Reactions : Monitor patients for infusion-related reactions. Interrupt and then reduce the rate or permanently discontinue based on the severity. ( 2.3 , 5.4 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Ocular Toxicity Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%) [see Adverse Reactions ( 6.1 )] . Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes. Keratopathy Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% of patients recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months). Visual Acuity Changes A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days). Monitoring and Patient Instruction Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity [see Dosage and Administration ( 2.3 )] . Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist [see Dosage and Administration ( 2.1 )] . Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS [see Warnings and Precautions ( 5.2 )] . 5.2 BLENREP REMS BLENREP is available only through a restricted program under a REMS called the BLENREP REMS because of the risks of ocular toxicity [see Warnings and Precautions ( 5.1 )] . Notable requirements of the BLENREP REMS include the following: • Prescribers must be certified with the program by enrolling and completing training in the BLENREP REMS. • Prescribers must counsel patients receiving BLENREP about the risk of ocular toxicity and the need for ophthalmic examinations prior to each dose. • Patients must be enrolled in the BLENREP REMS and comply with monitoring. • Healthcare facilities must be certified with the program and verify that patients are authorized to receive BLENREP. • Wholesalers and distributors must only distribute BLENREP to certified healthcare facilities. Further information is available, at www.BLENREPREMS.com and 1-855-209-9188. 5.3 Thrombocytopenia Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17% [see Adverse Reactions ( 6.1 )] . The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity [see Dosage and Administration ( 2.3 )] . 5.4 Infusion-Related Reactions Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8% [see Adverse Reactions ( 6.1 )] . Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate [see Dosage and Administration ( 2.3 )] . Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care. 5.5 Embryo-Fetal Toxicity Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Ocular toxicity [see Warnings and Precautions ( 5.1 )] . • Thrombocytopenia [see Warnings and Precautions ( 5.3 )] . • Infusion-related reactions [see Warnings and Precautions ( 5.4 )] . • The most common adverse reactions (≥20%) are keratopathy (corneal epithelium change on eye exam), decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. ( 6.1 ) • The most common grade 3 or 4 laboratory abnormalities (≥5%) are platelets decreased, lymphocytes decreased, hemoglobin decreased, neutrophils decreased, creatinine increased, and gamma-glutamyl transferase increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder. Among the 218 patients, 24% were exposed for 6 months or longer. Relapsed or Refractory Multiple Myeloma The safety of BLENREP as a single agent was evaluated in DREAMM-2 [see Clinical Studies ( 14.1 )] . Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Among these patients, 22% were exposed for 6 months or longer. Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%). Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation. Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%). Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%). The most common adverse reactions (≥20%) were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased, platelets decreased, hemoglobin decreased, neutrophils decreased, creatinine increased, and gamma-glutamyl transferase increased. Table 3 summarizes the adverse reactions in DREAMM-2 for patients who received the recommended dosage of 2.5 mg/kg once every 3 weeks. Table 3. Adverse Reactions (≥10%) in Patients Who Received BLENREP in DREAMM-2 a Keratopathy was based on slit lamp eye examination, characterized as corneal epithelium changes with or without symptoms. b Visual acuity changes were determined upon eye examination. c Blurred vision included diplopia, vision blurred, visual acuity reduced, and visual impairment. d Dry eyes included dry eye, ocular discomfort, and eye pruritus. e Fatigue included fatigue and asthenia. f Infusion-related reactions included infusion-related reaction, pyrexia, chills, diarrhea, nausea, asthenia, hypertension, lethargy, tachycardia. g Upper respiratory tract infection included upper respiratory tract infection, nasopharyngitis, rhinovirus infections, and sinusitis. Adverse Reactions BLENREP N = 95 All Grades (%) Grade 3-4 (%) Eye disorders Keratopathy a 71 44 Decreased visual acuity b 53 28 Blurred vision c 22 4 Dry eyes d 14 1 Gastrointestinal disorders Nausea 24 0 Constipation 13 0 Diarrhea 13 1 General disorders and administration site conditions Pyrexia 22 3 Fatigue e 20 2 Procedural complications Infusion-related reactions f 21 3 Musculoskeletal and connective tissue disorders Arthralgia 12 0 Back pain 11 2 Metabolic and nutritional disorders Decreased appetite 12 0 Infections Upper respiratory tract infection g 11 0 Clinically relevant adverse reactions in <10% of patients included: Eye Disorders: Photophobia, eye irritation, infective keratitis, ulcerative keratitis. Gastrointestinal Disorders: Vomiting. Infections: Pneumonia. Renal and Urinary Disorders: Albuminuria. Table 4 summarizes the laboratory abnormalities in DREAMM-2. Table 4. Laboratory Abnormalities (≥20%) Worsening from Baseline in Patients Who Received BLENREP in DREAMM-2 Laboratory Abnormality BLENREP N = 95 All Grades (%) Grades 3-4 (%) Hematology Platelets decreased 62 21 Lymphocytes decreased 49 22 Hemoglobin decreased 32 18 Neutrophils decreased 28 9 Chemistry Aspartate aminotransferase increased 57 2 Albumin decreased 43 4 Glucose increased 38 3 Creatinine increased 28 5 Alkaline phosphatase increased 26 1 Gamma-glutamyl transferase increased 25 5 Creatinine phosphokinase increased 22 1 Sodium decreased 21 2 Potassium decreased 20 2 Clinically relevant adverse reactions from expanded access programs include: pneumonitis including fatal cases. 6.2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. The immunogenicity of BLENREP was evaluated using an electrochemiluminescence (ECL)-based immunoassay to test for anti-belantamab mafodotin antibodies. In clinical studies of BLENREP, 2/274 patients (<1%) tested positive for anti-belantamab mafodotin antibodies after treatment. One of the 2 patients tested positive for neutralizing anti-belantamab mafodotin antibodies following 4 weeks on therapy. Due to the limited number of patients with antibodies against belantamab mafodotin-blmf, no conclusions can be drawn concerning a potential effect of immunogenicity on pharmacokinetics, efficacy, or safety.

<table ID="_Ref46135657" width="100%"><caption>Table 3. Adverse Reactions (&#x2265;10%) in Patients Who Received BLENREP in DREAMM-2</caption><col width="33%"/><col width="33%"/><col width="33%"/><tfoot><tr><td align="left" valign="top" styleCode="Botrule" colspan="3">^a Keratopathy was based on slit lamp eye examination, characterized as corneal epithelium changes with or without symptoms. ^b Visual acuity changes were determined upon eye examination. ^c Blurred vision included diplopia, vision blurred, visual acuity reduced, and visual impairment. ^d Dry eyes included dry eye, ocular discomfort, and eye pruritus. ^e Fatigue included fatigue and asthenia. ^f Infusion-related reactions included infusion-related reaction, pyrexia, chills, diarrhea, nausea, asthenia, hypertension, lethargy, tachycardia. ^g Upper respiratory tract infection included upper respiratory tract infection, nasopharyngitis, rhinovirus infections, and sinusitis.</td></tr></tfoot><tbody><tr><td rowspan="2" align="center" valign="bottom" styleCode="Rrule Botrule Lrule Toprule "><paragraph><content styleCode="bold">Adverse Reactions</content></paragraph></td><td colspan="2" align="center" valign="bottom" styleCode="Rrule Botrule Lrule Toprule "><paragraph><content styleCode="bold">BLENREP</content></paragraph><paragraph><content styleCode="bold">N = 95</content></paragraph></td></tr><tr><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">All Grades</content></paragraph><paragraph><content styleCode="bold">(%)</content></paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Grade 3-4</content></paragraph><paragraph><content styleCode="bold">(%)</content></paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Eye disorders</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Keratopathy^a</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>71</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>44</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Decreased visual acuity^b</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>53</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>28</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Blurred vision^c</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>22</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>4</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Dry eyes^d</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>14</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>1</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Gastrointestinal disorders</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Nausea</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>24</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>0</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Constipation</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>13</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>0</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Diarrhea</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>13</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>1</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">General disorders and administration site conditions</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Pyrexia</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>22</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>3</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Fatigue^e</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>20</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>2</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Procedural complications</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Infusion-related reactions^f</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>21</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>3</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Arthralgia</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>12</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>0</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Back pain</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>11</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>2</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Metabolic and nutritional disorders</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Decreased appetite</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>12</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>0</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Infections</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Botrule Lrule "><paragraph>Upper respiratory tract infection^g</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Botrule Lrule "><paragraph>11</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Botrule Lrule "><paragraph>0</paragraph></td></tr></tbody></table>

<table ID="_Ref46135683" width="100%"><caption>Table 4. Laboratory Abnormalities (&#x2265;20%) Worsening from Baseline in Patients Who Received BLENREP in DREAMM-2</caption><col width="33%"/><col width="33%"/><col width="33%"/><tbody><tr><td rowspan="2" align="center" valign="bottom" styleCode="Rrule Botrule Lrule Toprule "><paragraph><content styleCode="bold">Laboratory Abnormality</content></paragraph></td><td colspan="2" align="center" valign="bottom" styleCode="Rrule Botrule Lrule Toprule "><paragraph><content styleCode="bold">BLENREP</content></paragraph><paragraph><content styleCode="bold">N = 95</content></paragraph></td></tr><tr><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">All Grades</content></paragraph><paragraph><content styleCode="bold">(%)</content></paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Grades 3-4</content></paragraph><paragraph><content styleCode="bold">(%)</content></paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Hematology</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Platelets decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>62</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>21</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Lymphocytes decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>49</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>22</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Hemoglobin decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>32</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>18</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Neutrophils decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>28</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>9</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph><content styleCode="bold">Chemistry</content></paragraph></td><td valign="bottom" styleCode="Rrule Lrule Botrule "/><td valign="bottom" styleCode="Rrule Lrule Botrule "/></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Aspartate aminotransferase increased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>57</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>2</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Albumin decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>43</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>4</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Glucose increased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>38</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>3</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Creatinine increased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>28</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>5</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Alkaline phosphatase increased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>26</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>1</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Gamma-glutamyl transferase increased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>25</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>5</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Creatinine phosphokinase increased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>22</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>1</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Lrule Botrule "><paragraph>Sodium decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>21</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Lrule Botrule "><paragraph>2</paragraph></td></tr><tr><td valign="top" styleCode="Rrule Botrule Lrule "><paragraph>Potassium decreased</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Botrule Lrule "><paragraph>20</paragraph></td><td align="center" valign="bottom" styleCode="Rrule Botrule Lrule "><paragraph>2</paragraph></td></tr></tbody></table>