FDA label 052d1759-d9f2-6e44-e063-6394a90a482e

5 WARNINGS AND PRECAUTIONS QTc prolongation: Consider alternatives to efavirenz in patients taking other medications with a known risk of Torsade de Pointes or in patients at higher risk of Torsade de Pointes. ( 5.2 ) Do not use as a single agent or add on as a sole agent to a failing regimen. Consider potential for cross-resistance when choosing other agents. ( 5.3 ) Not recommended with ATRIPLA, which contains efavirenz, emtricitabine, and tenofovir disoproxil fumarate, unless needed for dose adjustment when coadministered with rifampin. ( 5.4 ) Serious psychiatric symptoms: Immediate medical evaluation is recommended for serious psychiatric symptoms such as severe depression or suicidal ideation. ( 5.5 , 17 ) Nervous system symptoms (NSS): NSS are frequent and usually begin 1-2 days after initiating therapy and resolve in 2-4 weeks. Dosing at bedtime may improve tolerability. NSS are not predictive of onset of psychiatric symptoms. ( 5.6, 6.1 , 17 ) Embryo-Fetal Toxicity: Avoid administration in the first trimester of pregnancy as fetal harm may occur. ( 5.7 , 8.1 ) Hepatotoxicity: Monitor liver function tests before and during treatment in patients with underlying hepatic disease, including hepatitis B or C coinfection, marked transaminase elevations, or who are taking medications associated with liver toxicity. Among reported cases of hepatic failure, a few occurred in patients with no pre-existing hepatic disease. ( 5.9 , 6.1 , 8.6 ) Rash: Rash usually begins within 1-2 weeks after initiating therapy and resolves within 4 weeks. Discontinue if severe rash develops. ( 5.8 , 6.1 , 17 ) Convulsions: Use caution in patients with a history of seizures. ( 5.10 ) Lipids: Total cholesterol and triglyceride elevations. Monitor before therapy and periodically thereafter. ( 5.11 ) Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.12 ) Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy. ( 5.13 , 17 ) 5.1 Drug Interactions Efavirenz plasma concentrations may be altered by substrates, inhibitors, or inducers of CYP3A. Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A or CYP2B6. The most prominent effect of efavirenz at steady-state is induction of CYP3A and CYP2B6 [ see Dosage and Administration ( 2.2 ) and Drug Interactions ( 7.1 )]. 5.2 QTc Prolongation QTc prolongation has been observed with the use of efavirenz [ see Drug Interactions ( 7.3 , 7.4 ) and Clinical Pharmacology ( 12.2 ) ]. Consider alternatives to efavirenz when coadministered with a drug with a known risk of Torsade de Pointes or when administered to patients at higher risk of Torsade de Pointes. 5.3 Resistance Efavirenz must not be used as a single agent to treat HIV-1 infection or added on as a sole agent to a failing regimen. Resistant virus emerges rapidly when efavirenz is administered as monotherapy. The choice of new antiretroviral agents to be used in combination with efavirenz should take into consideration the potential for viral cross-resistance. 5.4 Coadministration with Related Products Coadministration of efavirenz with ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is not recommended unless needed for dose adjustment (eg, with rifampin), since efavirenz is one of its active ingredients. 5.5 Psychiatric Symptoms Serious psychiatric adverse experiences have been reported in patients treated with efavirenz. In controlled trials of 1008 patients treated with regimens containing efavirenz for a mean of 2.1 years and 635 patients treated with control regimens for a mean of 1.5 years, the frequency (regardless of causality) of specific serious psychiatric events among patients who received efavirenz or control regimens, respectively, were severe depression (2.4%, 0.9%), suicidal ideation (0.7%, 0.3%), nonfatal suicide attempts (0.5%, 0), aggressive behavior (0.4%, 0.5%), paranoid reactions (0.4%, 0.3%), and manic reactions (0.2%, 0.3%). When psychiatric symptoms similar to those noted above were combined and evaluated as a group in a multifactorial analysis of data from Study 006, treatment with efavirenz was associated with an increase in the occurrence of these selected psychiatric symptoms. Other factors associated with an increase in the occurrence of these psychiatric symptoms were history of injection drug use, psychiatric history, and receipt of psychiatric medication at study entry; similar associations were observed in both the efavirenz and control treatment groups. In Study 006, onset of new serious psychiatric symptoms occurred throughout the study for both efavirenz-treated and control-treated patients. One percent of efavirenz-treated patients discontinued or interrupted treatment because of one or more of these selected psychiatric symptoms. There have also been occasional postmarketing reports of death by suicide, delusions, and psychosis-like behavior although a causal relationship to the use of efavirenz cannot be determined from these reports. Postmarketing cases of catatonia have also been reported and may be associated with increased efavirenz exposure. Patients with serious psychiatric adverse experiences should seek immediate medical evaluation to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits [ see Adverse Reactions ( 6.1 ) ]. 5.6 Nervous System Symptoms Fifty-three percent (531/1008) of patients receiving efavirenz in controlled trials reported central nervous system symptoms (any grade, regardless of causality) compared to 25% (156/635) of patients receiving control regimens [see Adverse Reactions ( 6.1 , Table 3 ) ]. These symptoms included, but were not limited to, dizziness (28.1% of the 1008 patients), insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%), and hallucinations (1.2%). These symptoms were severe in 2.0% of patients; and 2.1% of patients discontinued therapy as a result. These symptoms usually begin during the first or second day of therapy and generally resolve after the first 2-4 weeks of therapy. After 4 weeks of therapy, the prevalence of nervous system symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing efavirenz and from 3% to 5% in patients treated with a control regimen. Patients should be informed that these common symptoms were likely to improve with continued therapy and were not predictive of subsequent onset of the less frequent psychiatric symptoms [see Warnings and Precautions ( 5.5 ) ]. Dosing at bedtime may improve the tolerability of these nervous system symptoms [ see Dosage and Administration ( 2 ) ]. Analysis of long-term data from Study 006 (median follow-up 180 weeks, 102 weeks, and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the indinavir-containing control arm. Patients receiving efavirenz should be alerted to the potential for additive central nervous system effects when efavirenz is used concomitantly with alcohol or psychoactive drugs. Patients who experience central nervous system symptoms such as dizziness, impaired concentration, and/or drowsiness should avoid potentially hazardous tasks such as driving or operating machinery. 5.7 Embryo-Fetal Toxicity Efavirenz may cause fetal harm when administered during the first trimester to a pregnant woman. Advise females of reproductive potential who are receiving efavirenz to avoid pregnancy [ see Use in Specific Populations ( 8.1 and 8.3 ) ]. 5.8 Rash In controlled clinical trials, 26% (266/1008) of adult patients treated with 600 mg efavirenz experienced new-onset skin rash compared with 17% (111/635) of those treated in control groups [see Adverse Reactions ( 6.1 )]. Rash associated with blistering, moist desquamation, or ulceration occurred in 0.9% (9/1008) of patients treated with efavirenz. The incidence of Grade 4 rash (eg, erythema multiforme, Stevens-Johnson syndrome) in adult patients treated with efavirenz in all studies and expanded access was 0.1%. Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 2 weeks of initiating therapy with efavirenz (median time to onset of rash in adults was 11 days) and, in most patients continuing therapy with efavirenz, rash resolves within 1 month (median duration, 16 days). The discontinuation rate for rash in adult clinical trials was 1.7% (17/1008). Rash was reported in 59 of 182 pediatric patients (32%) treated with efavirenz [see Adverse Reactions ( 6.2 ) ]. Two pediatric patients experienced Grade 3 rash (confluent rash with fever, generalized rash), and four patients had Grade 4 rash (erythema multiforme). The median time to onset of rash in pediatric patients was 28 days (range 3-1642 days). Prophylaxis with appropriate antihistamines before initiating therapy with efavirenz in pediatric patients should be considered. Efavirenz can generally be reinitiated in patients interrupting therapy because of rash. Efavirenz should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever. Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash. For patients who have had a life-threatening cutaneous reaction (eg, Stevens-Johnson syndrome), alternative therapy should be considered [ see Contraindications ( 4 )]. 5.9 Hepatotoxicity Postmarketing cases of hepatitis, including fulminant hepatitis progressing to liver failure requiring transplantation or resulting in death, have been reported in patients treated with efavirenz. Reports have included patients with underlying hepatic disease, including coinfection with hepatitis B or C, and patients without pre-existing hepatic disease or other identifiable risk factors. Efavirenz is not recommended for patients with moderate or severe hepatic impairment. Careful monitoring is recommended for patients with mild hepatic impairment receiving efavirenz. [see Adverse Reactions ( 6.1 ) and Use in Specific Populations ( 8.6 ) ]. Monitoring of liver enzymes before and during treatment is recommended for all patients [see Dosage and Administration ( 2.1 ) ]. Consider discontinuing efavirenz in patients with persistent elevations of serum transaminases to greater than five times the upper limit of the normal range. Discontinue efavirenz if elevation of serum transaminases is accompanied by clinical signs or symptoms of hepatitis or hepatic decompensation. 5.10 Convulsions Convulsions have been observed in adult and pediatric patients receiving efavirenz, generally in the presence of known medical history of seizures [ see Nonclinical Toxicology ( 13.2 ) ]. Caution should be taken in any patient with a history of seizures. Patients who are receiving concomitant anticonvulsant medications primarily metabolized by the liver, such as phenytoin and phenobarbital, may require periodic monitoring of plasma levels [ see Drug Interactions ( 7.1 ) ]. 5.11 Lipid Elevations Treatment with efavirenz has resulted in increases in the concentration of total cholesterol and triglycerides [ see Adverse Reactions ( 6.1 ) ]. Cholesterol and triglyceride testing should be performed before initiating efavirenz therapy and at periodic intervals during therapy. 5.12 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including efavirenz. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barr¡SR syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment. 5.13 Fat Redistribution Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

6 ADVERSE REACTIONS Most common adverse reactions (>5%, moderate-severe) are impaired concentration, abnormal dreams, rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The most significant adverse reactions observed in patients treated with efavirenz are: psychiatric symptoms [ see Warnings and Precautions ( 5.5 ) ], nervous system symptoms [ see Warnings and Precautions ( 5.6 ) ], rash [ see Warnings and Precautions ( 5.8 ) ]. hepatotoxicity [see Warnings and Precautions ( 5.9 ) ]. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, the adverse reaction rates reported cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice. Adverse Reactions in Adults The most common (>5% in either efavirenz treatment group) adverse reactions of at least moderate severity among patients in Study 006 treated with efavirenz in combination with zidovudine/lamivudine or indinavir were rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting. Selected clinical adverse reactions of moderate or severe intensity observed in ≥2% of efavirenz-treated patients in two controlled clinical trials are presented in Table 2 . Table2:Selected Treatment-Emergent a Adverse Reactions of Moderate or Severe Intensity Reported in ≥2% of Efavirenz-Treated Patients in Studies 006 and ACTG364 a Includes adverse events at least possibly related to study drug or of unknown relationship for Study 006. Includes all adverse events regardless of relationship to study drug for Study ACTG 364. b Efavirenz provided as 600 mg once daily. c Median duration of treatment. d Includes erythema multiforme, rash, rash erythematous, rash follicular, rash maculopapular, rash petechial, rash pustular, and urticaria for Study 006 and macules, papules, rash, erythema, redness, inflammation, allergic rash, urticaria, welts, hives, itchy, and pruritus for ACTG 364. – = Not Specified. ZDV = zidovudine, LAM = lamivudine. Adverse Reactions Study 006 LAM-, NNRTI-, and Protease Inhibitor- Naive Patients Study ACTG 364 NNRTI- ,and Protease NRTI-experienced, Inhibitor-Naive Patients Efavirenz b +ZDV/LAM (n=412) 180 weeks c Efavirenz b +Indinavir (n=415) 102 weeks c Indinavir +ZDV/LAM (n=401) 76 weeks c Efavirenz b +Nelfinavir + NRTIs (n=64) 71.1 weeks c Efavirenz b +NRTIs (n=65) 70.9 weeks c Nelfinavir +NRTIs (n=66) 62.7 weeks c Body as a Whole Fatigue 8% 5% 9% 0 2% 3% Pain 1% 2% 8% 13% 6% 17% Central and Peripheral Nervous System Dizziness 9% 9% 2% 2% 6% 6% Headache 8% 5% 3% 5% 2% 3% Insomnia 7% 7% 2% 0 0 2% Concentration impaired 5% 3% <1% 0 0 0 Abnormal dreams 3% 1% 0 – – – Somnolence 2% 2% <1% 0 0 0 Anorexia 1% <1% <1% 0 2% 2% Gastrointestinal Nausea 10% 6% 24% 3% 2% 2% Vomiting 6% 3% 14% – – – Diarrhea 3% 5% 6% 14% 3% 9% Dyspepsia 4% 4% 6% 0 0 2% Abdominal pain 2% 2% 5% 3% 3% 3% Psychiatric Anxiety 2% 4% <1% – – – Depression 5% 4% <1% 3% 0 5% Nervousness 2% 2% 0 2% 0 2% Skin and Appendages Rash d 11% 16% 5% 9% 5% 9% Pruritus <1% 1% 1% 9% 5% 9% Pancreatitis has been reported, although a causal relationship with efavirenz has not been established. Asymptomatic increases in serum amylase levels were observed in a significantly higher number of patients treated with efavirenz 600 mg than in control patients (see Laboratory Abnormalities ). Nervous System Symptoms For 1008 patients treated with regimens containing efavirenz and 635 patients treated with a control regimen in controlled trials, Table 3 lists the frequency of symptoms of different degrees of severity and gives the discontinuation rates for one or more of the following nervous system symptoms: dizziness, insomnia, impaired concentration, somnolence, abnormal dreaming, euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal thinking, and depersonalization [see Warnings and Precautions ( 5.6 ) The frequencies of specific central and peripheral nervous system symptoms are provided in Table 2 . Table3:Percent of Patients with One or More Selected Nervous System Symptoms a,b a Includes events reported regardless of causality. b Data from Study 006 and three Phase 2/3 studies. c "Mild" = Symptoms which do not interfere with patient's daily activities. d "Moderate" = Symptoms which may interfere with daily activities. e "Severe" = Events which interrupt patient's usual daily activities. Percent of Patients with: Efavirenz 600 mg Once Daily (n=1008) % Control Groups (n=635) % Symptoms of any severity 52.7 24.6 Mild symptoms c 33.3 15.6 Moderate symptoms d 17.4 7.7 Severe symptoms e 2.0 1.3 Treatment discontinuation as a result of symptoms 2.1 1.1 Psychiatric Symptoms Serious psychiatric adverse experiences have been reported in patients treated with efavirenz. In controlled trials, psychiatric symptoms observed at a frequency greater than 2% among patients treated with efavirenz or control regimens, respectively, were depression (19%, 16%), anxiety (13%, 9%), and nervousness (7%, 2%). Rash In controlled clinical trials, the frequency of rash (all grades, regardless of causality) was 26% for 1008 adults treated with regimens containing efavirenz and 17% for 635 adults treated with a control regimen. Most reports of rash were mild or moderate in severity. The frequency of Grade 3 rash was 0.8% for efavirenz-treated patients and 0.3% for control groups, and the frequency of Grade 4 rash was 0.1% for efavirenz and 0 for control groups. The discontinuation rates as a result of rash were 1.7% for efavirenz-treated patients and 0.3% for control groups [see Warnings and Precautions ( 5.8 ) ]. Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited. Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz. Nine of these patients developed mild-to-moderate rash while receiving therapy with efavirenz, and two of these patients discontinued because of rash. Laboratory Abnormalities Selected Grade 3-4 laboratory abnormalities reported in ≥2% of efavirenz-treated patients in two clinical trials are presented in Table 4 . Table4:Selected Grade 3-4 Laboratory Abnormalites Reported in ≥2% of Efavirenz-Treated Patients in Studies 006 and ACTG364 a Efavirenz provided as 600 mg once daily. b Median duration of treatment. c Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction not associated with liver toxicity. d Nonfasting. ZDV = zidovudine, LAM = lamivudine, ULN = Upper limit of normal, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyltransferase. Variable Limit Study 006 LAM-, NNRTI -, Naive Patients and Protease Inhibitor- Study ACTG 364, NRTI-experienced, Protease Inhibitor NNRTI- and - Naive Patients Efavirenz a +ZDV/LAM (n=412) 180 weeks b Efavirenz a + Indinavir (n=415) 102 weeks b Indinavir + ZDV/ LAM (n=401) 76 weeks b Efavirenz a + Nelfinavir + NRTIs (n=64) 71.1 weeks b Efavirenz a + NRTIs (n=65) 70.9 weeks b Nelfinavir + NRTIs (n=66) 62.7 weeks b Chemistry ALT >5 × ULN 5% 8% 5% 2% 6% 3% AST >5 × ULN 5% 6% 5% 6% 8% 8% GGT c >5 × ULN 8% 7% 3% 5% 0 5% Amylase >2 × ULN 4% 4% 1% 0 6% 2% Glucose >250 mg/dL 3% 3% 3% 5% 2% 3% Triglycerides d ≥751 mg/dL 9% 6% 6% 11% 8% 17% Hematology Neutrophils <750/ mm 3 10% 3% 5% 2% 3% 2% Patients Coinfected with Hepatitis B or C Liver function tests should be monitored in patients with a history of hepatitis B and/or C. In the long-term data set from Study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive). Among these coinfected patients, elevations in AST to greater than five times ULN developed in 13% of patients in the efavirenz arms and 7% of those in the control arm, and elevations in ALT to greater than five times ULN developed in 20% of patients in the efavirenz arms and 7% of patients in the control arm. Among coinfected patients, 3% of those treated with efavirenz-containing regimens and 2% in the control arm discontinued from the study because of liver or biliary system disorders [ see Warnings and Precautions ( 5.9 ) ] . Lipids Increases from baseline in total cholesterol of 10-20% have been observed in some uninfected volunteers receiving efavirenz. In patients treated with efavirenz + zidovudine + lamivudine, increases from baseline in nonfasting total cholesterol and HDL of approximately 20% and 25%, respectively, were observed. In patients treated with efavirenz + indinavir, increases from baseline in nonfasting cholesterol and HDL of approximately 40% and 35%, respectively, were observed. Nonfasting total cholesterol levels ≥240 mg/dL and ≥300 mg/dL were reported in 34% and 9%, respectively, of patients treated with efavirenz + zidovudine + lamivudine; 54% and 20%, respectively, of patients treated with efavirenz + indinavir; and 28% and 4%, respectively, of patients treated with indinavir + zidovudine + lamivudine. The effects of efavirenz on triglycerides and LDL in this study were not well characterized since samples were taken from nonfasting patients. The clinical significance of these findings is unknown [ see Warnings and Precautions ( 5.11 ) ] . Adverse Reactions in Pediatric Patients Because clinical studies are conducted under widely varying conditions, the adverse reaction rates reported cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice. Assessment of adverse reactions is based on three clinical trials in 182 HIV-1 infected pediatric patients (3 months to 21 years of age) who received efavirenz in combination with other antiretroviral agents for a median of 123 weeks. The adverse reactions observed in the three trials were similar to those observed in clinical trials in adults except that rash was more common in pediatric patients (32% for all grades regardless of causality) and more often of higher grade (ie, more severe). Two (1.1%) pediatric patients experienced Grade 3 rash (confluent rash with fever, generalized rash), and four (2.2%) pediatric patients had Grade 4 rash (all erythema multiforme). Five pediatric patients (2.7%) discontinued from the study because of rash [ see Warnings and Precautions ( 5.8 ) ]. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of efavirenz. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: allergic reactions, asthenia, redistribution/accumulation of body fat [ see Warnings and Precautions ( 5.13 ) ]. Central and Peripheral Nervous System: abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor, vertigo Endocrine: gynecomastia Gastrointestinal: constipation, malabsorption Cardiovascular: flushing, palpitations Liver and Biliary System: hepatic enzyme increase, hepatic failure, hepatitis. Metabolic and Nutritional: hypercholesterolemia, hypertriglyceridemia Musculoskeletal: arthralgia, myalgia, myopathy Psychiatric: aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide, catatonia Respiratory: dyspnea Skin and Appendages: erythema multiforme, photoallergic dermatitis, Stevens-Johnson syndrome Special Senses: abnormal vision, tinnitus

<table ID="ID66" width="102%"><caption> Table2:Selected Treatment-Emergent ^aAdverse Reactions of Moderate or Severe Intensity Reported in &#x2265;2% of Efavirenz-Treated Patients in Studies 006 and ACTG364 </caption><col width="221"/><col width="170"/><col width="148"/><col width="170"/><col width="159"/><col width="178"/><col width="143"/><tfoot><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">^aIncludes adverse events at least possibly related to study drug or of unknown relationship for Study 006. Includes all adverse events regardless of relationship to study drug for Study ACTG 364. </paragraph></td></tr><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">^b Efavirenz provided as 600 mg once daily. </paragraph></td></tr><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">^c Median duration of treatment. </paragraph></td></tr><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">^d Includes erythema multiforme, rash, rash erythematous, rash follicular, rash maculopapular, rash petechial, rash pustular, and urticaria for Study 006 and macules, papules, rash, erythema, redness, inflammation, allergic rash, urticaria, welts, hives, itchy, and pruritus for ACTG 364. </paragraph></td></tr><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">&#x2013; = Not Specified.</paragraph></td></tr><tr><td align="left" colspan="7"><paragraph styleCode="Footnote">ZDV = zidovudine, LAM = lamivudine.</paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" align="center" styleCode="Lrule Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Adverse Reactions</content> </td><td align="right" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> Study 006</content> </td><td align="center" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> LAM-, NNRTI-, and </content> </td><td align="left" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Protease Inhibitor- Naive Patients</content> </td><td align="right" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> Study ACTG 364</content> <content styleCode="bold"> NNRTI- ,and Protease</content> </td><td align="left" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> NRTI-experienced, Inhibitor-Naive</content> </td><td align="left" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> </content> <content styleCode="bold"> Patients</content> </td></tr><tr><td align="center" styleCode=" Botrule Rrule" valign="bottom"> Efavirenz ^b +ZDV/LAM (n=412) 180 weeks ^c </td><td align="center" styleCode=" Botrule Rrule" valign="bottom"> Efavirenz ^b +Indinavir (n=415) 102 weeks ^c </td><td align="center" styleCode=" Botrule Rrule" valign="bottom"> Indinavir +ZDV/LAM (n=401) 76 weeks ^c </td><td align="center" styleCode=" Botrule Rrule" valign="bottom"> Efavirenz ^b +Nelfinavir + NRTIs (n=64) 71.1 weeks ^c </td><td align="center" styleCode=" Botrule Rrule" valign="bottom"> Efavirenz ^b +NRTIs (n=65) 70.9 weeks ^c </td><td align="center" styleCode=" Botrule Rrule" valign="bottom"> Nelfinavir +NRTIs (n=66) 62.7 weeks ^c </td></tr><tr><td colspan="7" align="left" styleCode="Lrule Botrule Rrule" valign="top"><content styleCode="bold"> Body</content><content styleCode="bold"> as</content><content styleCode="bold"> a</content><content styleCode="bold"> Whole</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Fatigue </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Pain </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 13% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 17% </td></tr><tr><td colspan="7" align="left" styleCode="Lrule Botrule Rrule" valign="top"><content styleCode="bold"> Central</content><content styleCode="bold"> and</content><content styleCode="bold"> Peripheral</content><content styleCode="bold"> Nervous</content><content styleCode="bold"> System</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Dizziness </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Headache </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Insomnia </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 7% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 7% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Concentration impaired </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Abnormal dreams </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Somnolence </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Anorexia </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr><tr><td colspan="7" align="left" styleCode="Lrule Botrule Rrule" valign="top"><content styleCode="bold"> Gastrointestinal</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Nausea </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 10% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 24% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Vomiting </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 14% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Diarrhea </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 14% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Dyspepsia </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 4% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 4% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Abdominal pain </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td></tr><tr><td colspan="7" align="left" styleCode="Lrule Botrule Rrule" valign="top"><content styleCode="bold"> Psychiatric</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Anxiety </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 4% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &#x2013; </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Depression </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 4% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Nervousness </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr><tr><td colspan="7" align="left" styleCode="Lrule Botrule Rrule" valign="top"><content styleCode="bold"> Skin</content><content styleCode="bold"> and</content><content styleCode="bold"> Appendages</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Rash ^d </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 11% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 16% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Pruritus </td><td align="center" styleCode=" Botrule Rrule" valign="top"> &lt;1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 9% </td></tr></tbody></table>

<table ID="ID68" width="85%"><caption> Table3:Percent of Patients with One or More Selected Nervous System Symptoms ^a,b</caption><col width="37%"/><col width="33%"/><col width="28%"/><tfoot><tr><td align="left" colspan="3"><paragraph styleCode="Footnote">^a Includes events reported regardless of causality. </paragraph></td></tr><tr><td align="left" colspan="3"><paragraph styleCode="Footnote">^b Data from Study 006 and three Phase 2/3 studies. </paragraph></td></tr><tr><td align="left" colspan="3"><paragraph styleCode="Footnote">^c &quot;Mild&quot; = Symptoms which do not interfere with patient&apos;s daily activities. </paragraph></td></tr><tr><td align="left" colspan="3"><paragraph styleCode="Footnote">^d &quot;Moderate&quot; = Symptoms which may interfere with daily activities. </paragraph></td></tr><tr><td align="left" colspan="3"><paragraph styleCode="Footnote">^e &quot;Severe&quot; = Events which interrupt patient&apos;s usual daily activities. </paragraph></td></tr></tfoot><tbody><tr><td align="center" styleCode="Lrule Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Percent</content><content styleCode="bold"> of</content><content styleCode="bold"> Patients</content><content styleCode="bold"> with:</content> </td><td align="center" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Efavirenz</content><content styleCode="bold"> 600</content><content styleCode="bold"> mg</content><content styleCode="bold"> Once</content><content styleCode="bold"> Daily</content> <content styleCode="bold"> (n=1008)</content> <content styleCode="bold"> %</content> </td><td align="center" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Control</content><content styleCode="bold"> Groups</content> <content styleCode="bold"> (n=635)</content> <content styleCode="bold"> %</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Symptoms of any severity </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 52.7 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 24.6 </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Mild symptoms ^c </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 33.3 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 15.6 </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Moderate symptoms ^d </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 17.4 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 7.7 </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Severe symptoms ^e </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2.0 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1.3 </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Treatment discontinuation as a result of symptoms </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 2.1 </td><td align="center" styleCode=" Botrule Rrule" valign="top"> 1.1 </td></tr></tbody></table>

<table ID="ID72" width="85%"><caption> Table4:Selected Grade 3-4 Laboratory Abnormalites Reported in &#x2265;2% of Efavirenz-Treated Patients in Studies 006 and ACTG364 </caption><col width="14%"/><col width="13%"/><col width="12%"/><col width="9%"/><col width="14%"/><col width="11%"/><col width="11%"/><col width="12%"/><tfoot><tr><td align="left" colspan="8"><paragraph styleCode="Footnote">^a Efavirenz provided as 600 mg once daily. </paragraph></td></tr><tr><td align="left" colspan="8"><paragraph styleCode="Footnote">^b Median duration of treatment. </paragraph></td></tr><tr><td align="left" colspan="8"><paragraph styleCode="Footnote">^c Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction not associated with liver toxicity. </paragraph></td></tr><tr><td align="left" colspan="8"><paragraph styleCode="Footnote">^d Nonfasting. </paragraph></td></tr><tr><td align="left" colspan="8"><paragraph styleCode="Footnote">ZDV = zidovudine, LAM = lamivudine, ULN = Upper limit of normal, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyltransferase.</paragraph></td></tr></tfoot><tbody><tr><td align="center" styleCode="Lrule Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Variable</content> </td><td align="center" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> Limit</content> </td><td align="right" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> Study 006 LAM-, </content> </td><td align="center" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> NNRTI -, </content> <content styleCode="bold"> Naive Patients</content> </td><td align="left" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> and Protease Inhibitor-</content> </td><td align="right" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> Study ACTG 364, </content> </td><td align="center" styleCode=" Toprule Botrule" valign="top"><content styleCode="bold"> NRTI-experienced,</content> <content styleCode="bold"> Protease Inhibitor </content> </td><td align="left" styleCode=" Toprule Botrule Rrule" valign="top"><content styleCode="bold"> NNRTI- and </content> <content styleCode="bold"> - Naive Patients</content> </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> </td><td align="left" styleCode=" Botrule Rrule" valign="top"> </td><td align="center" styleCode=" Botrule Rrule" valign="top"> Efavirenz ^a +ZDV/LAM (n=412) 180 weeks ^b </td><td align="center" styleCode=" Botrule Rrule" valign="top"> Efavirenz ^a + Indinavir (n=415) 102 weeks ^b </td><td align="center" styleCode=" Botrule Rrule" valign="top"> Indinavir + ZDV/ LAM (n=401) 76 weeks ^b </td><td align="center" styleCode=" Botrule Rrule" valign="top"> Efavirenz ^a + Nelfinavir + NRTIs (n=64) 71.1 weeks ^b </td><td align="center" styleCode=" Botrule Rrule" valign="top"> Efavirenz ^a + NRTIs (n=65) 70.9 weeks ^b </td><td align="center" styleCode=" Botrule Rrule" valign="top"> Nelfinavir + NRTIs (n=66) 62.7 weeks ^b </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Chemistry </td><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> ALT </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &gt;5 &#xD7; ULN </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> AST </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &gt;5 &#xD7; ULN </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 8% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> GGT ^c </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &gt;5 &#xD7; ULN </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 7% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Amylase </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &gt;2 &#xD7; ULN </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 4% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 4% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 1% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 0 </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Glucose </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &gt;250 mg/dL </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Triglycerides ^d </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &#x2265;751 mg/dL </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 9% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 6% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 11% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 8% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 17% </td></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Hematology </td><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/><td styleCode=" Botrule Rrule" valign="top"/></tr><tr><td align="left" styleCode="Lrule Botrule Rrule" valign="top"> Neutrophils </td><td align="left" styleCode=" Botrule Rrule" valign="top"> &lt;750/ mm ³ </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 10% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 5% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 2% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 3% </td><td align="left" styleCode=" Botrule Rrule" valign="top"> 2% </td></tr></tbody></table>