FDA label 8d8f5dd5-879b-4f1a-a239-74ae9eb358fc

WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK. (5.1) Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated. (5.2) WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES See full prescribing information for complete boxed warning. Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK. ( 5.1 ) Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated. ( 5.2 )

5 WARNINGS AND PRECAUTIONS Hemorrhage: Fatal and serious cases of gastrointestinal and pulmonary hemorrhage. Monitor platelet counts and transfuse as needed. ( 5.3 ) Hepatotoxicity: Monitor hepatic enzymes and adjust dosage if abnormal liver function tests are observed during FARYDAK therapy. ( 5.6 ) Embryo-Fetal Toxicity: can cause fetal harm. Advise women of the potential hazard to the fetus and to avoid pregnancy while taking FARYDAK. ( 5.7 ) 5.1 Diarrhea Severe diarrhea occurred in 25% of patients treated with FARYDAK [see Adverse Reactions (6.1)] . Diarrhea of any grade occurred in 68% of patients treated with FARYDAK compared to 42% of patients in the control arm. Diarrhea can occur at any time. Monitor patient hydration status and electrolyte blood levels, including potassium, magnesium and phosphate, at baseline and weekly (or more frequently as clinically indicated) during therapy and correct to prevent dehydration and electrolyte disturbances. Initiate anti-diarrheal medication at the onset of diarrhea. Interrupt FARYDAK at the onset of moderate diarrhea (4 to 6 stools per day) [see Dosage and Administration (2.3)] . Ensure that patients initiating therapy with FARYDAK have anti-diarrheal medications on hand. 5.2 Cardiac Toxicities Severe and fatal cardiac ischemic events, as well as severe arrhythmias, and electrocardiogram (ECG) changes occurred in patients receiving FARYDAK. Arrhythmias occurred in 12% of patients receiving FARYDAK, compared to 5% of patients in the control arm. Cardiac ischemic events occurred in 4% of patients treated with FARYDAK compared with 1% of patients in the control arm. Do not initiate FARYDAK treatment in patients with history of recent myocardial infarction or unstable angina. Electrocardiographic abnormalities such as ST-segment depression and T-wave abnormalities also occurred more frequently in patients receiving FARYDAK compared to the control arm: 22% versus 4% and 40% versus 18%, respectively. FARYDAK may prolong cardiac ventricular repolarization (QT interval). Do not initiate treatment with FARYDAK in patients with a QTcF >450 msec or clinically significant baseline ST-segment or T-wave abnormalities. Arrhythmias may be exacerbated by electrolyte abnormalities. If during treatment with FARYDAK, the QTcF increases to ≥480 msec, interrupt treatment. Correct any electrolyte abnormalities. If QT prolongation does not resolve, permanently discontinue treatment with FARYDAK. Obtain ECG at baseline and periodically during treatment as clinically indicated. Monitor electrolytes during treatment with FARYDAK and correct abnormalities as clinically indicated. 5.3 Hemorrhage Fatal and serious hemorrhage occurred during treatment with FARYDAK. In the clinical trial in patients with relapsed multiple myeloma, 5 patients receiving FARYDAK compared to 1 patient in the control arm died due to a hemorrhagic event. All 5 patients had grade ≥3 thrombocytopenia at the time of the event. Grade 3/4 hemorrhage was reported in 4% of patients treated with the FARYDAK arm and 2% of patients in the control arm. 5.4 Myelosuppression FARYDAK causes myelosuppression, including severe thrombocytopenia, neutropenia and anemia. In the clinical trial in patients with relapsed multiple myeloma, 67% of patients treated with FARYDAK developed Grade 3 to 4 thrombocytopenia compared with 31% in the control arm. Thrombocytopenia led to treatment interruption and or dose modification in 31% of patients receiving FARYDAK compared to 11% of patients in the control arm. For patients receiving FARYDAK, 33% required platelet transfusion compared to 10% of patients in the control arm [see Dosage and Administration (2.2)] . Severe neutropenia occurred in 34% of patients treated with FARYDAK, compared to 11% of patients in the control arm. Neutropenia led to treatment interruption and or dose modification in 10% of patients receiving FARYDAK. The use of granulocyte-colony stimulating factor (G-CSF) was higher in patients treated with FARYDAK compared to the control arm, 13% compared to 4%, respectively. Obtain a baseline CBC and monitor the CBC weekly during treatment (or more frequently if clinically indicated). Dose modifications are recommended for Myelosuppression [see Dosage and Administration (2.2)] . Monitor CBCs more frequently in patients over 65 years of age due to the increased frequency of myelosuppression in these patients [see Use in Specific Populations (8.5)] . 5.5 Infections Localized and systemic infections, including pneumonia, bacterial infections, invasive fungal infections, and viral infections have been reported in patients taking FARYDAK. Severe infections occurred in 31% of patients (including 10 deaths) treated with FARYDAK compared with 24% of patients (including 6 deaths) in the control arm. Infections of all grades occurred at a similar rate between arms. FARYDAK treatment should not be initiated in patients with active infections. Monitor patients for signs and symptoms of infections during treatment; if a diagnosis of infection is made, institute appropriate anti-infective treatment promptly and consider interruption or discontinuation of FARYDAK. 5.6 Hepatotoxicity Hepatic dysfunction, primarily elevations in aminotransferases and total bilirubin, occurred in patients treated with FARYDAK. Liver function should be monitored prior to treatment and regularly during treatment. If abnormal liver function tests are observed dose adjustments may be considered and the patient should be followed until values return to normal or pretreatment levels [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)] . 5.7 Embryo-Fetal Toxicity FARYDAK can cause fetal harm when administered to a pregnant woman. Panobinostat was teratogenic in rats and rabbits. If FARYDAK is used during pregnancy, or if the patient becomes pregnant while taking FARYDAK, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1, 8.3)] . Advise females of reproductive potential to avoid becoming pregnant while taking FARYDAK. Advise sexually-active females of reproductive potential to use effective contraception while taking FARYDAK and for at least 3 months after the last dose of FARYDAK. Advise sexually active men to use condoms while on treatment and for 6 months after their last dose of FARYDAK [see Use in Specific Populations (8.3)] .

6 ADVERSE REACTIONS The following adverse reactions are described in detail in other sections of the label: Diarrhea [see Warnings and Precautions (5.1)] Cardiac Toxicities [see Warnings and Precautions (5.2)] Hemorrhage [see Warnings and Precautions (5.3)] Myelosuppression [see Warnings and Precautions (5.4)] Infections [see Warnings and Precautions (5.5)] Hepatotoxicity [see Warnings and Precautions (5.6)] 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 most common adverse reactions (incidence of at least 20%) in clinical studies are diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia, and vomiting. ( 6.1 ) The most common non-hematologic laboratory abnormalities (incidence ≥40%) are hypophosphatemia, hypokalemia, hyponatremia, and increased creatinine. The most common hematologic laboratory abnormalities (incidence ≥60%) are thrombocytopenia, lymphopenia, leukopenia, neutropenia, and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The safety data reflect subject exposure to FARYDAK from a clinical trial, in which 758 subjects with relapsed multiple myeloma received FARYDAK in combination with bortezomib and dexamethasone or placebo in combination with bortezomib and dexamethasone (referred to as the control arm). The median duration of exposure to FARYDAK was 5 months with 16% of patients exposed to study treatment for ≥48 weeks. Serious adverse events (SAEs) occurred in 60% of patients in the FARYDAK, bortezomib, and dexamethasone compared to 42% of patients in the control arm. The most frequent (≥5%) treatment-emergent SAEs reported for patients treated with FARYDAK were pneumonia (18%), diarrhea, (11%), thrombocytopenia (7%), fatigue (6%), and sepsis (6%). Adverse reactions that led to discontinuation of FARYDAK occurred in 36% of patients. The most common adverse reactions leading to treatment discontinuations were diarrhea, fatigue, and pneumonia. Deaths occurred in 8% of patients in the FARYDAK arm versus 5% on the control arm. The most frequent causes of death were infection and hemorrhage. Table 4 summarizes the adverse reactions occurring in at least 10% of patients with ≥ 5% greater incidence in the FARYDAK arm, and Table 5 summarizes the treatment-emergent laboratory abnormalities. Table 4: Adverse Reactions (≥10% Incidence and ≥5% Greater Incidence in FARYDAK-Arm) in Patients with Multiple Myeloma [1] BTZ = bortezomib [2] Dex = dexamethasone [3] Arrhythmia includes the terms: arrhythmia, arrhythmia supraventricular, atrial fibrillation, atrial flutter, atrial tachycardia, bradycardia, cardiac arrest, cardio-respiratory arrest, sinus bradycardia, sinus tachycardia, supraventricular extra-systoles, tachycardia, ventricular arrhythmia, and ventricular tachycardia [4] Fatigue includes the terms: fatigue, malaise, asthenia, and lethargy Primary System Organ Class Preferred term FARYDAK, BTZ [1] , Dex [2] N=381 All grades % FARYDAK, BTZ [1] , Dex [2] N=381 Grade 3/4 % Placebo, BTZ [1] , Dex [2] N=377 All grades % Placebo, BTZ [1] , Dex [2] N=377 Grade 3/4 % Cardiac disorders Arrhythmia [3] 12 3 5 2 Gastrointestinal disorders Diarrhea 68 25 42 8 Nausea 36 6 21 1 Vomiting 26 7 13 1 General disorders and administration site conditions Fatigue [4] 60 25 42 12 Peripheral edema 29 2 19 <1 Pyrexia 26 1 15 2 Investigations Weight decreased 12 2 5 1 Metabolism and nutrition disorders Decreased appetite 28 3 12 1 Other Adverse Reactions Other notable adverse drug reactions of FARYDAK not described above, which were either clinically significant, or occurred with a frequency less than 10% but had a frequency in the FARYDAK arm greater than 2% over the control arm in the multiple myeloma clinical trial are listed below: Infections and infestations: hepatitis B. Endocrine disorders: hypothyroidism. Metabolism and nutrition disorders: hyperglycemia, dehydration, fluid retention, hyperuricemia, hypomagnesemia. Nervous system disorders: dizziness, headache, syncope, tremor, dysgeusia. Cardiac disorders: palpitations. Vascular disorders: hypotension, hypertension, orthostatic hypotension. Respiratory, thoracic and mediastinal disorders: cough, dyspnea, respiratory failure, rales, wheezing. Gastrointestinal disorders: abdominal pain, dyspepsia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence, colitis, gastrointestinal pain. Skin and subcutaneous disorders: skin lesions, rash, erythema. Musculoskeletal and connective tissue disorders: joint swelling. Renal and urinary disorders: renal failure, urinary incontinence. General disorders and administration site conditions: chills. Investigations: blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased. Psychiatric disorders: insomnia. Table 5: Treatment-emergent Laboratory Abnormalities (≥10% Incidence and ≥5% Greater Incidence in FARYDAK-arm) in Patients with Multiple Myeloma [1] BTZ = bortezomib [2] Dex = dexamethasone Investigations FARYDAK, BTZ [1] , Dex [2] N=381 Any grade % FARYDAK, BTZ [1] , Dex [2] N=381 Grade 3/4 % Placebo, BTZ [1] , Dex [2] N=377 Any grade % Placebo, BTZ [1] , Dex [2] N=377 Grade 3/4 % Hematology Thrombocytopenia 97 67 83 31 Anemia 62 18 52 19 Neutropenia 75 34 36 11 Leukopenia 81 23 48 8 Lymphopenia 82 53 74 40 Chemistry Blood creatinine increased 41 1 23 2 Hypokalemia 52 18 36 7 Hypophosphatemia 63 20 45 12 Hyponatremia 49 13 36 7 Hyperbilirubinemia 21 1 13 <1 Hypocalcemia 67 5 55 2 Hypoalbuminemia 63 2 38 2 Hyperphosphatemia 29 2 20 <1 Hypermagnesemia 27 5 14 1 Fatigue and Asthenia Grade 1 to Grade 4 asthenic conditions (fatigue, malaise, asthenia, and lethargy) were reported in 60% of the patients in the FARYDAK arm compared to 42% of patients in the control arm. Grade ≥3 asthenic conditions were reported in 25% of the patients in the FARYDAK arm compared to 12% of patients in the control arm. Asthenic conditions led to treatment discontinuation in 6% of patients in the FARYDAK arm versus 3% of patients in the control arm. The prespecified sub-group upon which the efficacy and safety of FARYDAK was based had a similar adverse reaction profile to the entire safety population of patients treated with FARYDAK, bortezomib, and dexamethasone.

<table><caption>Table 4: Adverse Reactions (&#x2265;10% Incidence and &#x2265;5% Greater Incidence in FARYDAK-Arm) in Patients with Multiple Myeloma</caption><col width="350"/><col width="200"/><col width="200"/><col width="200"/><col width="200"/><tfoot><tr><td colspan="5">^[1] BTZ = bortezomib</td></tr><tr><td colspan="5">^[2] Dex = dexamethasone</td></tr><tr><td colspan="5">^[3] Arrhythmia includes the terms: arrhythmia, arrhythmia supraventricular, atrial fibrillation, atrial flutter, atrial tachycardia, bradycardia, cardiac arrest, cardio-respiratory arrest, sinus bradycardia, sinus tachycardia, supraventricular extra-systoles, tachycardia, ventricular arrhythmia, and ventricular tachycardia</td></tr><tr><td colspan="5">^[4] Fatigue includes the terms: fatigue, malaise, asthenia, and lethargy</td></tr></tfoot><tbody><tr><td styleCode="Toprule Lrule Rrule " valign="bottom"><content styleCode="bold">Primary System Organ Class Preferred term</content></td><td styleCode="Toprule Lrule Rrule" align="center" valign="bottom"><content styleCode="bold">FARYDAK, BTZ ^[1], Dex ^[2] N=381 All grades %</content></td><td styleCode="Toprule Lrule Rrule" align="center" valign="bottom"><content styleCode="bold">FARYDAK, BTZ ^[1], Dex ^[2] N=381 Grade 3/4 %</content></td><td styleCode="Toprule Lrule Rrule" align="center" valign="bottom"><content styleCode="bold">Placebo, BTZ ^[1], Dex ^[2] N=377 All grades %</content></td><td styleCode="Toprule Lrule Rrule" align="center" valign="bottom"><content styleCode="bold">Placebo, BTZ ^[1], Dex ^[2] N=377 Grade 3/4 %</content></td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">Cardiac disorders</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Arrhythmia^[3]</td><td styleCode="Toprule Lrule Rrule" align="center">12</td><td styleCode="Toprule Lrule Rrule" align="center">3</td><td styleCode="Toprule Lrule Rrule" align="center">5</td><td styleCode="Toprule Lrule Rrule" align="center">2</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">Gastrointestinal disorders</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Diarrhea</td><td styleCode="Toprule Lrule Rrule" align="center">68</td><td styleCode="Toprule Lrule Rrule" align="center">25</td><td styleCode="Toprule Lrule Rrule" align="center">42</td><td styleCode="Toprule Lrule Rrule" align="center">8</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Nausea</td><td styleCode="Toprule Lrule Rrule" align="center">36</td><td styleCode="Toprule Lrule Rrule" align="center">6</td><td styleCode="Toprule Lrule Rrule" align="center">21</td><td styleCode="Toprule Lrule Rrule" align="center">1</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Vomiting</td><td styleCode="Toprule Lrule Rrule" align="center">26</td><td styleCode="Toprule Lrule Rrule" align="center">7</td><td styleCode="Toprule Lrule Rrule" align="center">13</td><td styleCode="Toprule Lrule Rrule" align="center">1</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">General disorders and administration site conditions</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Fatigue^[4]</td><td styleCode="Toprule Lrule Rrule" align="center">60</td><td styleCode="Toprule Lrule Rrule" align="center">25</td><td styleCode="Toprule Lrule Rrule" align="center">42</td><td styleCode="Toprule Lrule Rrule" align="center">12</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Peripheral edema</td><td styleCode="Toprule Lrule Rrule" align="center">29</td><td styleCode="Toprule Lrule Rrule" align="center">2</td><td styleCode="Toprule Lrule Rrule" align="center">19</td><td styleCode="Toprule Lrule Rrule" align="center">&lt;1</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Pyrexia</td><td styleCode="Toprule Lrule Rrule" align="center">26</td><td styleCode="Toprule Lrule Rrule" align="center">1</td><td styleCode="Toprule Lrule Rrule" align="center">15</td><td styleCode="Toprule Lrule Rrule" align="center">2</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">Investigations</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Weight decreased</td><td styleCode="Toprule Lrule Rrule" align="center">12</td><td styleCode="Toprule Lrule Rrule" align="center">2</td><td styleCode="Toprule Lrule Rrule" align="center">5</td><td styleCode="Toprule Lrule Rrule" align="center">1</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">Metabolism and nutrition disorders</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Decreased appetite</td><td styleCode="Toprule Lrule Rrule" align="center">28</td><td styleCode="Toprule Lrule Rrule" align="center">3</td><td styleCode="Toprule Lrule Rrule" align="center">12</td><td styleCode="Toprule Lrule Rrule" align="center">1</td></tr></tbody></table>

<table><caption>Table 5: Treatment-emergent Laboratory Abnormalities (&#x2265;10% Incidence and &#x2265;5% Greater Incidence in FARYDAK-arm) in Patients with Multiple Myeloma</caption><col width="350"/><col width="200"/><col width="200"/><col width="200"/><col width="200"/><tfoot><tr><td colspan="5">^[1] BTZ = bortezomib</td></tr><tr><td colspan="5">^[2] Dex = dexamethasone</td></tr></tfoot><tbody><tr><td styleCode="Toprule Lrule Rrule " valign="bottom"><content styleCode="bold">Investigations</content></td><td styleCode="Toprule Lrule Rrule" align="center" valign="bottom"><content styleCode="bold">FARYDAK, BTZ^[1], Dex^[2] N=381 Any grade %</content></td><td styleCode="Toprule Lrule Rrule" align="center"><content styleCode="bold">FARYDAK, BTZ^[1], Dex^[2] N=381 Grade 3/4 %</content></td><td styleCode="Toprule Lrule Rrule" align="center"><content styleCode="bold">Placebo, BTZ^[1], Dex^[2] N=377 Any grade %</content></td><td styleCode="Toprule Lrule Rrule" align="center"><content styleCode="bold">Placebo, BTZ^[1], Dex^[2] N=377 Grade 3/4 %</content></td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">Hematology</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Thrombocytopenia</td><td styleCode="Toprule Lrule Rrule" align="center">97</td><td styleCode="Toprule Lrule Rrule" align="center">67</td><td styleCode="Toprule Lrule Rrule" align="center">83</td><td styleCode="Toprule Lrule Rrule" align="center">31</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Anemia</td><td styleCode="Toprule Lrule Rrule" align="center">62</td><td styleCode="Toprule Lrule Rrule" align="center">18</td><td styleCode="Toprule Lrule Rrule" align="center">52</td><td styleCode="Toprule Lrule Rrule" align="center">19</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Neutropenia</td><td styleCode="Toprule Lrule Rrule" align="center">75</td><td styleCode="Toprule Lrule Rrule" align="center">34</td><td styleCode="Toprule Lrule Rrule" align="center">36</td><td styleCode="Toprule Lrule Rrule" align="center">11</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Leukopenia</td><td styleCode="Toprule Lrule Rrule" align="center">81</td><td styleCode="Toprule Lrule Rrule" align="center">23</td><td styleCode="Toprule Lrule Rrule" align="center">48</td><td styleCode="Toprule Lrule Rrule" align="center">8</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Lymphopenia</td><td styleCode="Toprule Lrule Rrule" align="center">82</td><td styleCode="Toprule Lrule Rrule" align="center">53</td><td styleCode="Toprule Lrule Rrule" align="center">74</td><td styleCode="Toprule Lrule Rrule" align="center">40</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="5"><content styleCode="bold">Chemistry</content></td></tr><tr><td styleCode="Toprule Lrule Rrule ">Blood creatinine increased</td><td styleCode="Toprule Lrule Rrule" align="center">41</td><td styleCode="Toprule Lrule Rrule" align="center">1</td><td styleCode="Toprule Lrule Rrule" align="center">23</td><td styleCode="Toprule Lrule Rrule" align="center">2</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hypokalemia</td><td styleCode="Toprule Lrule Rrule" align="center">52</td><td styleCode="Toprule Lrule Rrule" align="center">18</td><td styleCode="Toprule Lrule Rrule" align="center">36</td><td styleCode="Toprule Lrule Rrule" align="center">7</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hypophosphatemia</td><td styleCode="Toprule Lrule Rrule" align="center">63</td><td styleCode="Toprule Lrule Rrule" align="center">20</td><td styleCode="Toprule Lrule Rrule" align="center">45</td><td styleCode="Toprule Lrule Rrule" align="center">12</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hyponatremia</td><td styleCode="Toprule Lrule Rrule" align="center">49</td><td styleCode="Toprule Lrule Rrule" align="center">13</td><td styleCode="Toprule Lrule Rrule" align="center">36</td><td styleCode="Toprule Lrule Rrule" align="center">7</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hyperbilirubinemia</td><td styleCode="Toprule Lrule Rrule" align="center">21</td><td styleCode="Toprule Lrule Rrule" align="center">1</td><td styleCode="Toprule Lrule Rrule" align="center">13</td><td styleCode="Toprule Lrule Rrule" align="center">&lt;1</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hypocalcemia</td><td styleCode="Toprule Lrule Rrule" align="center">67</td><td styleCode="Toprule Lrule Rrule" align="center">5</td><td styleCode="Toprule Lrule Rrule" align="center">55</td><td styleCode="Toprule Lrule Rrule" align="center">2</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hypoalbuminemia</td><td styleCode="Toprule Lrule Rrule" align="center">63</td><td styleCode="Toprule Lrule Rrule" align="center">2</td><td styleCode="Toprule Lrule Rrule" align="center">38</td><td styleCode="Toprule Lrule Rrule" align="center">2</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hyperphosphatemia</td><td styleCode="Toprule Lrule Rrule" align="center">29</td><td styleCode="Toprule Lrule Rrule" align="center">2</td><td styleCode="Toprule Lrule Rrule" align="center">20</td><td styleCode="Toprule Lrule Rrule" align="center">&lt;1</td></tr><tr><td styleCode="Toprule Lrule Rrule ">Hypermagnesemia</td><td styleCode="Toprule Lrule Rrule" align="center">27</td><td styleCode="Toprule Lrule Rrule" align="center">5</td><td styleCode="Toprule Lrule Rrule" align="center">14</td><td styleCode="Toprule Lrule Rrule" align="center">1</td></tr></tbody></table>