FDA label f604dd4b-ccda-4085-b673-f48ef074aff8

WARNING: ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death ( 1 ) . Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Flebogamma ® 5% DIF does not contain sucrose. (See Dosage and Administration [ 2.3 ] and Warnings and Precautions [ 5.2 ] for important information intended to reduce the risk of acute renal failure.) WARNING: ACUTE RENAL DYSFUNCTION AND FAILURE See full prescribing information for complete boxed warning. Immune globulin intravenous (IGIV) products, particularly those with sucrose, have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. For patients pre-disposed to renal dysfunction or failure, administer Flebogamma 5% DIF at the minimum concentration available and the minimum infusion rate practicable. Flebogamma 5% DIF does not contain sucrose.

5 WARNINGS AND PRECAUTIONS IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have Epinephrine immediately available to treat any acute severe hypersensitivity reactions. [ 5.1 ] Monitor renal function, including blood urea nitrogen, serum creatinine and urine output in patients at risk of developing acute renal failure. [ 5.2 ] Hyperproteinemia, with resultant changes in serum osmolarity and electrolyte imbalances may occur in patients receiving IGIV therapy. [ 5.3 ] Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events and consider baseline assessment of blood viscosity for those at risk of hyperviscosity. [ 5.4 ] Aseptic Meningitis Syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [ 5.5 ] Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. Monitor patients for hemolysis and hemolytic anemia. [ 5.6 ] Monitor patients for pulmonary adverse reactions (TRALI). [ 5.7 ] Flebogamma 5% DIF is made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. [ 5.8 ] Transitory rise of various passively transferred antibodies in patient blood may yield positive serological testing results. [ 5.9 ] Patients receiving Flebogamma 5% DIF for first time or being restarted on product after treatment hiatus of more than 8 weeks may be at higher risk for development fever, chills nausea, and vomiting. [ 5.10 ] 5.1 Hypersensitivity Severe hypersensitivity reactions may occur. In case of hypersensitivity, discontinue Flebogamma ® 5% DIF infusion immediately and institute appropriate treatment. Have Epinephrine immediately available for treatment of acute severe hypersensitivity reactions. Flebogamma ® 5% DIF contains trace amounts of IgA (less than 50 µg/mL). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Flebogamma ® 5% DIF is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction. Rarely, Immune Globulin Intravenous (Human) can induce a severe fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with IGIV. In the case of shock, the current standard medical treatment for shock should be implemented. 5.2 Renal Failure Assure that patients are not volume depleted prior to the initiation of the infusion of Flebogamma ® 5% DIF. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure (1) . Assess renal function, including measurement of BUN/serum creatinine, before the initial infusion of Flebogamma ® 5% DIF and at appropriate intervals thereafter. If renal function deteriorates, consider discontinue use of the product. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, administer Flebogamma ® 5% DIF at the minimum rate of infusion practicable (2). (See Boxed Warning ) (See Dosing and Administration [ 2.3 ] ) 5.3 Hyperproteinemia Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving Flebogamma ® 5% DIF. It is clinically critical to distinguishing true hyponatremia from a pseudohyponatremia that is caused by a decreased calculated serum osmolarity or elevated osmolar gap because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events. 5.4 Thromboembolytic Events Thrombotic events may occur during or following IGIV treatment (11 – 13) . Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, or known/suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer Flebogamma ® 5% DIF at the minimum rate of infusion practicable. 5.5 Aseptic Meningitis Syndrome (AMS) AMS may occur infrequently with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae (3 – 6) . AMS usually begins within several hours to 2 days following IGIV treatment. AMS is characterized by the following symptoms and signs: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cubic milliliter, predominantly from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. Provide a thorough neurological examination to patients exhibiting such symptoms and signs, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently following high-dose (e.g., > 1.0 g/kg body weight) and/or rapid-infusion IGIV treatment. Patients with a history of migraine may be more susceptible. (See Patient Counseling Information [ 17 ]) 5.6 Hemolysis Flebogamma ® 5% DIF may contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis (7 – 9). Hemolytic anemia may develop subsequent to Flebogamma ® 5% DIF therapy due to enhanced RBC sequestration (10). Monitor patients for clinical signs and symptoms of hemolysis. If these are present after Flebogamma ® 5% DIF infusion, perform appropriate confirmatory laboratory testing. (See Patient Counseling Information [ 17 ]) 5.7 Transfusion-Related Acute Lung Injury (TRALI) Non-cardiogenic pulmonary edema may occur in patients following IGIV treatment (14) . This Transfusion-Related Acute Lung Injury (TRALI) is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours after transfusion. Monitor patients for pulmonary adverse reactions. (See Patient Counseling Information [ 17 ]) If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies in both the product and patient serum. Patients with TRALI may be managed by using oxygen therapy with adequate ventilatory support. 5.8 Infectious Disease Transmission Flebogamma ® 5% DIF is made from human plasma. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk of transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for Flebogamma ® 5% DIF. (See Patient Counseling Information [ 17 ]) 5.9 Laboratory Tests After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of Flebogamma ® 5% DIF and at appropriate intervals thereafter. Consider baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. 5.10 Special Care Precautions All patients, but especially individuals receiving Flebogamma ® 5% DIF for the first time or being restarted on the product after a treatment hiatus of more than 8 weeks, may be at a higher risk for the development of inflammatory reactions characterized by fever, chills, nausea, and vomiting. Careful monitoring of recipients and adherence to recommendations regarding information in the Dosage and Administration [ 2.3 ] section may reduce the risk of these types of events.

5.1 Hypersensitivity Severe hypersensitivity reactions may occur. In case of hypersensitivity, discontinue Flebogamma ® 5% DIF infusion immediately and institute appropriate treatment. Have Epinephrine immediately available for treatment of acute severe hypersensitivity reactions. Flebogamma ® 5% DIF contains trace amounts of IgA (less than 50 µg/mL). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Flebogamma ® 5% DIF is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction. Rarely, Immune Globulin Intravenous (Human) can induce a severe fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with IGIV. In the case of shock, the current standard medical treatment for shock should be implemented.

5.2 Renal Failure Assure that patients are not volume depleted prior to the initiation of the infusion of Flebogamma ® 5% DIF. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure (1) . Assess renal function, including measurement of BUN/serum creatinine, before the initial infusion of Flebogamma ® 5% DIF and at appropriate intervals thereafter. If renal function deteriorates, consider discontinue use of the product. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, administer Flebogamma ® 5% DIF at the minimum rate of infusion practicable (2). (See Boxed Warning ) (See Dosing and Administration [ 2.3 ] )

5.3 Hyperproteinemia Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving Flebogamma ® 5% DIF. It is clinically critical to distinguishing true hyponatremia from a pseudohyponatremia that is caused by a decreased calculated serum osmolarity or elevated osmolar gap because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events.

6 ADVERSE REACTIONS The most common temporally related adverse reactions (≥ 5%) occurring during or within 72 hours of the end of an infusion observed for PI were: headache, chills, fever, shaking, fatigue, malaise, anxiety, back pain, muscle cramps, abdominal cramps, blood pressure changes, chest tightness, palpitations, tachycardia, nausea, vomiting, cutaneous reactions, wheezing, rash, arthralgia, and edema (see Table 1 ). The adverse reactions often begin within 60 minutes of the start of the infusion. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals at 1-888-GRIFOLS (1-888‑474‑3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The most common temporally related adverse reactions with an incidence ≥ 5% include: headache, chills, fever, shaking, fatigue, malaise, anxiety, back pain, muscle cramps, abdominal cramps, blood pressure changes, chest tightness, palpitations, tachycardia, nausea, vomiting, cutaneous reactions, wheezing, rash, arthralgia, and edema. [ 6 ] To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals at 1-888-GRIFOLS (1-888‑474‑3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies 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 clinical practice. Adverse events were reported in a study of 46 individuals with primary humoral immunodeficiency diseases receiving infusions every 3 to 4 weeks of 300 to 600 mg/kg body weight. Forty-three (94%) subjects experienced at least 1 adverse event irrespective of the relationship with the product, and these subjects reported a total of 595 adverse events. None of the 46 subjects who participated in this study discontinued the study prematurely due to an adverse event considered related to the study drug. One subject had treatment-emergent bronchiestasis, mild, ongoing, after infusion #10; and one subject had recurrent moderate leucopenia after the 7 th and 12 th infusions. Adverse events that occurred with an incidence of ≥ 5% on a per subject basis are summarized in Table 1. Table 1. Adverse Events Occurring with an Incidence of ≥ 5% Irrespective of Causality Adverse Event Subjects (%) [N = 46] Infusions* (%) [N = 709] Sinusitis 20 (44) 5 (0.7) Pyrexia 17 (37) 15 (2) Headache 16 (35) 26 (4) Upper respiratory tract infection 15 (33) 6 (0.8) Combined bronchitis [1] 14 (30) 9 (1) Cough or Productive cough 10 (22) 3 (0.4) Diarrhoea 9 (20) 7 (1) Pharyngitis 8 (17) 3 (0.4) Asthma 8 (17) 0 (0) Infusion site reaction [2] 7 (15) 13 (2) Nasal congestion 7 (15) 0 (0) Arthralgia 7 (15) 1 (0.1) Nausea 6 (13) 3 (0.4) Postnasal drip 6 (13) 2 (0.3) Dizziness 6 (13) 1 (0.1) Joint problems [3] 5 (11) 0 (0) Rigors 5 (11) 6 (0.8) Conjunctivitis 5 (11) 2 (0.3) Nasopharyngitis 5 (11) 2 (0.3) Rhinorrhea 5 (11) 3 (0.4) Back pain 4 (9) 5 (0.7) Dyspnoea 4 (9) 1 (0.1) Abdominal pain 4 (9) 1 (0.1) Gastroenteritis 4 (9) 0 (0) Dermatitis contact 4 (9) 2 (0.3) Urticaria 4 (9) 3 (0.4) Anemia 4 (9) 1 (0.1) Erythema 4 (9) 4 (0.6) Myalgia 3 (7) 2 (0.3) Pain 3 (7) 5 (0.7) Fatigue 3 (7) 1 (0.1) Wheezing 3 (7) 1 (0.1) Dyspepsia 3 (7) 0 (0) Toothache 3 (7) 1 (0.1) Sinus congestion 3 (7) 1 (0.1) Muscle strain 3 (7) 1 (0.1) Thermal burn 3 (7) 1 (0.1) Abrasion 3 (7) 0 (0) Eczema 3 (7) 1 (0.1) Rash papular 3 (7) 1 (0.1) * Number of infusions for which AE onset occurred during an infusion or within 72 hours post-infusion. [1] Includes reported preferred terms of Bronchiectasis NOS, Bronchitis NOS, and Bronchitis acute NOS. [2] Corresponds to preferred term of Injection site reaction NOS. If combined to include Infusion site inflammation, Injection site oedema, Injection site pain, Injection site pruritis, Injection site reaction NOS, and Injection site swelling, there are 9 (20) subjects and 17 (2) infusions. [3] Includes reported preferred terms of Bursitis, Chondromalacia patellae, Epicondylitis, Joint sprain, Joint swelling, Tenosynovitis, and Trigger finger. The total number of AEs (regardless of attribution) reported whose onset were within 72 hours after the end of an infusion of Flebogamma ® 5% DIF was 216. There were a total of 709 infusions, resulting in a rate of 0.305 (upper bound 95% CI=41.2%) temporally associated AEs per infusion. There were 144 infusions (20.1%, 1-sided 95% upper bound CI = 24.4%) associated with 1 or more AEs that began within 72 hours after the completion of an infusion. A summary of infusions with mild, moderate, and severe treatment-related adverse events is in Table 2. Table 2. Summary of Infusions with Mild, Moderate, and Severe Treatment-Related Adverse Events Severity of AE No. Infusions with AE Adjusted % Adjusted % = average of the % of infusions with a treatment-related adverse event for each individual subject . Confidence Interval The 95% upper bound for the adjusted % of infusions for which at least 1 treatment-related adverse event was reported was derived by using the t-statistic. Mild 58 7.9 10.4 Moderate 25 3.6 4.9 Severe 1 0.1 0.3 The number and percent of subjects with treatment-emergent rises in AST or ALT are in Table 3. Table 3. Number (%) of Subjects with Treatment-Emergent Rises in AST or ALT (N = 46) Laboratory Test Assessment Criteria n % AST Above 3x the ULN ULN = upper limit of normal. 3 6.5 ALT Above 3x the ULN 1 2.2 None of these subjects had a concomitant treatment-emergent rise in total bilirubin. 6.2 Post-marketing Experience The following adverse reactions have been identified during the post-approval use of IGIV products, including Flebogamma ® 5% DIF [see References [ 15 ] ]. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a casual relationship to exposure to the product. Respiratory Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm Cardiovascular Cardiac arrest, thromboembolism, vascular collapse, hypotension Neurological Coma, loss of consciousness, seizures, tremor Integumentary Stevens-Johnson Syndrome, epidermolysis, erythema multiformae, bullous dermatitis Hematologic Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test Musculoskeletal Back pain Gastrointestinal Hepatic dysfunction, abdominal pain General/Body as a Whole Pyrexia, rigors

6.1 Clinical Studies 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 clinical practice. Adverse events were reported in a study of 46 individuals with primary humoral immunodeficiency diseases receiving infusions every 3 to 4 weeks of 300 to 600 mg/kg body weight. Forty-three (94%) subjects experienced at least 1 adverse event irrespective of the relationship with the product, and these subjects reported a total of 595 adverse events. None of the 46 subjects who participated in this study discontinued the study prematurely due to an adverse event considered related to the study drug. One subject had treatment-emergent bronchiestasis, mild, ongoing, after infusion #10; and one subject had recurrent moderate leucopenia after the 7 th and 12 th infusions. Adverse events that occurred with an incidence of ≥ 5% on a per subject basis are summarized in Table 1. Table 1. Adverse Events Occurring with an Incidence of ≥ 5% Irrespective of Causality Adverse Event Subjects (%) [N = 46] Infusions* (%) [N = 709] Sinusitis 20 (44) 5 (0.7) Pyrexia 17 (37) 15 (2) Headache 16 (35) 26 (4) Upper respiratory tract infection 15 (33) 6 (0.8) Combined bronchitis [1] 14 (30) 9 (1) Cough or Productive cough 10 (22) 3 (0.4) Diarrhoea 9 (20) 7 (1) Pharyngitis 8 (17) 3 (0.4) Asthma 8 (17) 0 (0) Infusion site reaction [2] 7 (15) 13 (2) Nasal congestion 7 (15) 0 (0) Arthralgia 7 (15) 1 (0.1) Nausea 6 (13) 3 (0.4) Postnasal drip 6 (13) 2 (0.3) Dizziness 6 (13) 1 (0.1) Joint problems [3] 5 (11) 0 (0) Rigors 5 (11) 6 (0.8) Conjunctivitis 5 (11) 2 (0.3) Nasopharyngitis 5 (11) 2 (0.3) Rhinorrhea 5 (11) 3 (0.4) Back pain 4 (9) 5 (0.7) Dyspnoea 4 (9) 1 (0.1) Abdominal pain 4 (9) 1 (0.1) Gastroenteritis 4 (9) 0 (0) Dermatitis contact 4 (9) 2 (0.3) Urticaria 4 (9) 3 (0.4) Anemia 4 (9) 1 (0.1) Erythema 4 (9) 4 (0.6) Myalgia 3 (7) 2 (0.3) Pain 3 (7) 5 (0.7) Fatigue 3 (7) 1 (0.1) Wheezing 3 (7) 1 (0.1) Dyspepsia 3 (7) 0 (0) Toothache 3 (7) 1 (0.1) Sinus congestion 3 (7) 1 (0.1) Muscle strain 3 (7) 1 (0.1) Thermal burn 3 (7) 1 (0.1) Abrasion 3 (7) 0 (0) Eczema 3 (7) 1 (0.1) Rash papular 3 (7) 1 (0.1) * Number of infusions for which AE onset occurred during an infusion or within 72 hours post-infusion. [1] Includes reported preferred terms of Bronchiectasis NOS, Bronchitis NOS, and Bronchitis acute NOS. [2] Corresponds to preferred term of Injection site reaction NOS. If combined to include Infusion site inflammation, Injection site oedema, Injection site pain, Injection site pruritis, Injection site reaction NOS, and Injection site swelling, there are 9 (20) subjects and 17 (2) infusions. [3] Includes reported preferred terms of Bursitis, Chondromalacia patellae, Epicondylitis, Joint sprain, Joint swelling, Tenosynovitis, and Trigger finger. The total number of AEs (regardless of attribution) reported whose onset were within 72 hours after the end of an infusion of Flebogamma ® 5% DIF was 216. There were a total of 709 infusions, resulting in a rate of 0.305 (upper bound 95% CI=41.2%) temporally associated AEs per infusion. There were 144 infusions (20.1%, 1-sided 95% upper bound CI = 24.4%) associated with 1 or more AEs that began within 72 hours after the completion of an infusion. A summary of infusions with mild, moderate, and severe treatment-related adverse events is in Table 2. Table 2. Summary of Infusions with Mild, Moderate, and Severe Treatment-Related Adverse Events Severity of AE No. Infusions with AE Adjusted % Adjusted % = average of the % of infusions with a treatment-related adverse event for each individual subject . Confidence Interval The 95% upper bound for the adjusted % of infusions for which at least 1 treatment-related adverse event was reported was derived by using the t-statistic. Mild 58 7.9 10.4 Moderate 25 3.6 4.9 Severe 1 0.1 0.3 The number and percent of subjects with treatment-emergent rises in AST or ALT are in Table 3. Table 3. Number (%) of Subjects with Treatment-Emergent Rises in AST or ALT (N = 46) Laboratory Test Assessment Criteria n % AST Above 3x the ULN ULN = upper limit of normal. 3 6.5 ALT Above 3x the ULN 1 2.2 None of these subjects had a concomitant treatment-emergent rise in total bilirubin.

6.2 Post-marketing Experience The following adverse reactions have been identified during the post-approval use of IGIV products, including Flebogamma ® 5% DIF [see References [ 15 ] ]. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a casual relationship to exposure to the product. Respiratory Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm Cardiovascular Cardiac arrest, thromboembolism, vascular collapse, hypotension Neurological Coma, loss of consciousness, seizures, tremor Integumentary Stevens-Johnson Syndrome, epidermolysis, erythema multiformae, bullous dermatitis Hematologic Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test Musculoskeletal Back pain Gastrointestinal Hepatic dysfunction, abdominal pain General/Body as a Whole Pyrexia, rigors

<table ID="c3f8780a-449d-410a-b037-c4aea50cd9c5" width="800"> <colgroup> <col align="left"/> <col align="center"/> <col align="center"/> </colgroup> <thead styleCode="Lrule Rrule Toprule Botrule"> <tr> <th styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold"> <content styleCode="emphasis"> </content> </content> <content styleCode="bold"> <content styleCode="emphasis"> Adverse Event </content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold"> <content styleCode="emphasis"> </content> </content> <content styleCode="bold"> <content styleCode="emphasis">Subjects (%) [N = 46]</content> </content> </th> <th styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold"> <content styleCode="emphasis"> </content> </content> <content styleCode="bold"> <content styleCode="emphasis">Infusions* (%) [N = 709]</content> </content> <content styleCode="bold"> <content styleCode="emphasis"> </content> </content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Sinusitis</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">20 (44)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (0.7)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Pyrexia</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">17 (37)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">15 (2)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Headache</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">16 (35)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">26 (4)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Upper respiratory tract infection</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">15 (33)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">6 (0.8)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Combined bronchitis [1]</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">14 (30)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">9 (1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Cough or Productive cough</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">10 (22)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (0.4)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Diarrhoea</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">9 (20)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">7 (1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Pharyngitis</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">8 (17)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (0.4)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Asthma</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">8 (17)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">0 (0)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Infusion site reaction [2]</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">7 (15)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">13 (2)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Nasal congestion</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">7 (15)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">0 (0)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Arthralgia</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">7 (15)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Nausea</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">6 (13)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (0.4)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Postnasal drip</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">6 (13)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">2 (0.3)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Dizziness</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">6 (13)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Joint problems [3]</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (11)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">0 (0)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Rigors</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (11)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">6 (0.8)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Conjunctivitis</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (11)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">2 (0.3)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Nasopharyngitis</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (11)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">2 (0.3)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Rhinorrhea</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (11)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (0.4)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Back pain</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (0.7)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Dyspnoea</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Abdominal pain</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Gastroenteritis</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">0 (0)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Dermatitis contact</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">2 (0.3)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Urticaria</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (0.4)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Anemia</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Erythema</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (9)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">4 (0.6)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Myalgia</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">2 (0.3)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Pain</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">5 (0.7)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Fatigue</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Wheezing</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Dyspepsia</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">0 (0)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Toothache</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Sinus congestion</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Muscle strain</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Thermal burn</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Abrasion</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">0 (0)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Eczema</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> Rash papular</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">3 (7)</content> </content> </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">1 (0.1)</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="3" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> ^{* Number of infusions for which AE onset occurred during an infusion or within 72 hours post-infusion.} </content> </content> </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> ^{[1] Includes reported preferred terms of Bronchiectasis NOS, Bronchitis NOS, and Bronchitis acute NOS.} </content> </content> </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> ^{[2] Corresponds to preferred term of Injection site reaction NOS. If combined to include Infusion site inflammation, Injection site oedema, Injection site pain, Injection site pruritis, Injection site reaction NOS, and Injection site swelling, there are 9 (20) subjects and 17 (2) infusions.} </content> </content> </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="emphasis"> ^{[3] Includes reported preferred terms of Bursitis, Chondromalacia patellae, Epicondylitis, Joint sprain, Joint swelling, Tenosynovitis, and Trigger finger.} </content> </content> </paragraph> </td> </tr> </tbody> </table>