OPZELURA

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Invasive fungal infections, including cryptococcosis, and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA [see Warnings and Precautions ( 5.1 )] . MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a h igher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions ( 5.2 )] . MALIGNANCIES Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions ( 5.3 )] . MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events ( MACE) ( defined as cardiovascular death, myocardial infarction, and stroke) , was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke [see Warnings and Precautions ( 5.4 )] . THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately [see Warnings and Precautions ( 5.5 )] . WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Janus kinase inhibitors for inflammatory conditions. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. ( 5.2 ) Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. ( 5.3 ) Higher rate of MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. ( 5.4 ) Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with Janus kinase inhibitors for inflammatory conditions. ( 5.5 )

5 WARNINGS AND PRECAUTIONS Serious Infections: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Regularly monitor patients for infection and manage it promptly. ( 5.1 ) Non-melanoma Skin Cancers . Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and following treatment as appropriate. ( 5.3 ) Thrombosis. Thromboembolic events have occurred. ( 5.5 ) Cytopenias: Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia have occurred. Perform CBC monitoring as clinically indicated. ( 5.6 ) Potential Risks Related to JAK Inhibition: Treatment with oral JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Treatment with oral JAK inhibitors has been associated with hypoglycemia in patients with diabetes. ( 5.7 ) 5.1 Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral JAK inhibitors. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OPZELURA in patients: with chronic or recurrent infection with a history of a serious or an opportunistic infection who have been exposed to tuberculosis who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Interrupt OPZELURA if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume OPZELURA until the infection is controlled. Tuberculosis No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral JAK inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with JAK inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves. Hepatitis B and C The impact of JAK inhibitors used to treat inflammatory conditions including OPZELURA on chronic viral hepatitis reactivation is unknown. Patients with a history of hepatitis B or C infection were excluded from clinical trials. Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C. 5.2 Mortality In a large, randomized, postmarketing safety study of an oral JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA. 5.3 Malignancy and Lymphoproliferative Disorders Malignancies, including lymphomas, were observed in clinical trials of oral JAK inhibitors used to treat inflammatory conditions. Patients who are current or past smokers are at additional increased risk. Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions. In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers. Non-melanoma Skin Cancers Non-melanoma skin cancers including basal cell and squamous cell carcinoma have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen. 5.4 Major Adverse Cardiovascular Events (MACE) In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke. 5.5 Thrombosis Thromboembolic events were observed in clinical trials with OPZELURA. Thrombosis, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In a large, randomized, postmarketing safety study of an oral JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. Avoid OPZELURA in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue OPZELURA and evaluate and treat patients appropriately. 5.6 Cytopenias Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. Discontinue OPZELURA if signs and/or symptoms associated with clinically significant decreases in laboratory values occur. 5.7 Potential Risks Related to JAK Inhibition Treatment with oral JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Treatment with oral JAK inhibitors has been associated with hypoglycemia in patients with diabetes.

6 ADVERSE REACTIONS In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reactions, pyrexia, and white blood cell decreased. ( 6 ) In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Subjects 2 Years of Age and Older with Atopic Dermatitis Adult and Pediatric Subjects 12 Years of Age and Older In two double-blind, vehicle-controlled clinical trials (TRuE-AD1 and TRuE-AD2), 499 adult and pediatric subjects 12 years of age and older with atopic dermatitis were treated topically with OPZELURA twice daily for 8 weeks [see Clinical Studies ( 14.1 )] . The adverse reactions reported by ≥ 1% of OPZELURA treated subjects and at a greater incidence than in the vehicle arm are listed in Table 1. Table 1: Adverse Reactions Occurring in ≥ 1% of Adult and Pediatric Subjects 12 Years of Age and Older Treated with OPZELURA for Atopic Dermatitis through Week 8 in TRuE-AD1 and TRuE-AD2 Adverse Reaction OPZELURA (N = 499) n (%) Vehicle (N = 250) n (%) Nasopharyngitis 13 (3) 2 (1) Bronchitis 4 (1) 0 (0) Ear infection 4 (1) 0 (0) Eosinophil count increased 4 (1) 0 (0) Urticaria 4 (1) 0 (0) Diarrhea 3 (1) 1 (< 1) Folliculitis 3 (1) 0 (0) Tonsillitis 3 (1) 0 (0) Rhinorrhea 3 (1) 1 (< 1) Adverse reactions that occurred in TRuE-AD1 and TRuE-AD2 in < 1% of subjects in the OPZELURA group and none in the vehicle group were: neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, Staphylococcal infection, and acneiform dermatitis. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects 12 to 17 years of age. Pediatric Subjects 2 to 11 Years of Age In a double-blind, vehicle-controlled clinical trial (TRuE-AD3), 130 pediatric subjects 2 to 11 years of age with mild to moderate atopic dermatitis were treated topically with OPZELURA twice daily for 8 weeks [see Clinical Studies ( 14.1 )] . The adverse reactions reported by ≥ 1% of subjects treated with OPZELURA and at a greater incidence than in the vehicle arm are listed in Table 2. Table 2: Adverse Reactions Occurring in ≥ 1% Pediatric Subjects 2 to 11 Years of Age Treated with OPZELURA for Atopic Dermatitis through Week 8 in TRuE-AD3 Adverse Reaction OPZELURA (N = 130) n (%) Vehicle (N = 65) n (%) Upper respiratory tract infection Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, rhinorrhea, oropharyngeal pain, respiratory tract congestion, viral upper respiratory tract infection 20 (15) 7 (11) COVID-19 6 (5) 2 (3) Application site reaction Application site reaction includes application site pain, application site irritation, application site discomfort, application site pruritus 6 (5) 1 (2) Pyrexia 3 (2) 0 (0) White blood cell decreased White blood cell decreased includes white blood cell decreased, leukopenia 2 (2) 0 (0) Subjects with cytopenias (defined as hemoglobin < 10 g/dL, absolute neutrophil count (ANC) < 1000/μL, and platelet count < 100,000/μL) at screening were excluded from the trial. The impact of OPZELURA on blood cell counts in this population has not been studied. Adverse Reactions in Adult and Pediatric Subjects 12 Years of Age and Older with Nonsegmental Vitiligo In two double-blind, vehicle-controlled clinical trials (TRuE-V1 and TRuE-V2), 449 adult and pediatric subjects 12 years of age and older with nonsegmental vitiligo were treated topically with OPZELURA twice daily for 24 weeks [see Clinical Studies ( 14.2 )] . The adverse reactions reported by OPZELURA treated subjects with an incidence of ≥ 1% and at least 1% greater incidence than in the vehicle arm in the 24-week double-blind period are listed in Table 3. Table 3: Adverse Reactions Occurring in ≥ 1% of Adult and Pediatric Subjects 12 Years of Age and Older Treated with OPZELURA for Nonsegmental Vitiligo through Week 24 in TRuE-V1 and TRuE-V2 Adverse Reaction OPZELURA (N = 449) n (%) Vehicle (N = 224) n (%) Application site acne 26 (6) 2 (1) Application site pruritus 23 (5) 6 (3) Nasopharyngitis 19 (4) 5 (2) Headache 17 (4) 6 (3) Urinary tract infection 7 (2) 1 (< 1) Application site erythema 7 (2) 1 (< 1) Pyrexia 6 (1) 0 Adverse reactions that occurred in TRuE-V1 and TRuE-V2 in ≥ 0.5% to < 1% of subjects in the OPZELURA group and none in the vehicle group were: application site dermatitis, hypertension, anxiety, application site discoloration, application site folliculitis, dermatitis contact, diarrhea, ear infection, gastritis, gastroenteritis, hordeolum, influenza-like illness, insomnia, nasal congestion, and vomiting. No clinically meaningful differences in safety or effectiveness were observed between adults and pediatric subjects.

<table width="716px"><caption>Table 1: Adverse Reactions Occurring in &#x2265; 1% of Adult and Pediatric Subjects 12 Years of Age and Older Treated with OPZELURA for Atopic Dermatitis through Week 8 in TRuE-AD1 and TRuE-AD2</caption><col/><col width="35%"/><col width="35%"/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold"> Adverse Reaction</content></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">OPZELURA (N = 499) n (%)</content></paragraph></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Vehicle (N = 250) n (%)</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Nasopharyngitis</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">13 (3)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2 (1)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Bronchitis</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">4 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Ear infection</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">4 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Eosinophil count increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">4 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Urticaria</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">4 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Diarrhea</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1 (&lt; 1)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Folliculitis</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Tonsillitis </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Rhinorrhea</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1 (&lt; 1)</td></tr></tbody></table>

<table width="554px"><caption>Table 2: Adverse Reactions Occurring in &#x2265; 1% Pediatric Subjects 2 to 11 Years of Age Treated with OPZELURA for Atopic Dermatitis through Week 8 in TRuE-AD3</caption><col/><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">OPZELURA (N = 130) n (%) </content></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Vehicle (N = 65) n (%)</content></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Upper respiratory tract infection<footnote ID="FOOT_25217">Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, rhinorrhea, oropharyngeal pain, respiratory tract congestion, viral upper respiratory tract infection</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">20 (15)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7 (11) </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">COVID-19 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">6 (5)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2 (3) </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Application site reaction<footnote ID="FOOT_25218">Application site reaction includes application site pain, application site irritation, application site discomfort, application site pruritus</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">6 (5)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1 (2) </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Pyrexia </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3 (2) </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0) </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">White blood cell decreased<footnote ID="FOOT_25219"><paragraph>White blood cell decreased includes white blood cell decreased, leukopenia</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2 (2) </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 (0) </td></tr></tbody></table>

<table width="660.2px"><caption>Table 3: Adverse Reactions Occurring in &#x2265; 1% of Adult and Pediatric Subjects 12 Years of Age and Older Treated with OPZELURA for Nonsegmental Vitiligo through Week 24 in TRuE-V1 and TRuE-V2</caption><col/><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"> <content styleCode="bold">OPZELURA (N = 449) n (%)</content></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"> <content styleCode="bold">Vehicle (N = 224) n (%)</content></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Application site acne</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">26 (6)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2 (1)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Application site pruritus</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">23 (5)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">6 (3)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Nasopharyngitis</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">19 (4)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">5 (2)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Headache</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17 (4)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">6 (3)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Urinary tract infection</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7 (2)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1 (&lt; 1)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Application site erythema</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7 (2)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1 (&lt; 1)</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"> Pyrexia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">6 (1)</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr></tbody></table>