6 ADVERSE REACTIONS The most common adverse reaction (incidence ≥2%) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 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. The safety of EKTERLY is based on data from a double-blind, randomized, placebo-controlled, three-way, crossover clinical trial (KONFIDENT) [see Clinical Studies ( 14 )] . In KONFIDENT, a total of 110 patients aged 12 years and older with HAE treated 264 attacks. In the safety population, 93 patients received EKTERLY 600 mg, 86 patients received EKTERLY 300 mg, and 83 patients received placebo. While EKTERLY 300 mg was included in KONFIDENT, the safety data is based on the recommended dosage of EKTERLY 600 mg. Table 3 displays adverse reaction(s) with an incidence of ≥2% in the EKTERLY 600 mg treated patients and more common than placebo. Table 3: Adverse Reaction(s) with EKTERLY with Incidence ≥2% and More Common than Placebo in Patients with Hereditary Angioedema (KONFIDENT) a One (1) patient assigned to administer placebo actually received EKTERLY 600 mg. Safety results are presented by actual treatment received. Adverse Reaction EKTERLY 600 mg (N = 93) Placebo (N = 83) a n (%) n (%) Headache 3 (3.2) 1 (1.2)
adverse reactions
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. The safety of EKTERLY is based on data from a double-blind, randomized, placebo-controlled, three-way, crossover clinical trial (KONFIDENT) [see Clinical Studies ( 14 )] . In KONFIDENT, a total of 110 patients aged 12 years and older with HAE treated 264 attacks. In the safety population, 93 patients received EKTERLY 600 mg, 86 patients received EKTERLY 300 mg, and 83 patients received placebo. While EKTERLY 300 mg was included in KONFIDENT, the safety data is based on the recommended dosage of EKTERLY 600 mg. Table 3 displays adverse reaction(s) with an incidence of ≥2% in the EKTERLY 600 mg treated patients and more common than placebo. Table 3: Adverse Reaction(s) with EKTERLY with Incidence ≥2% and More Common than Placebo in Patients with Hereditary Angioedema (KONFIDENT) a One (1) patient assigned to administer placebo actually received EKTERLY 600 mg. Safety results are presented by actual treatment received. Adverse Reaction EKTERLY 600 mg (N = 93) Placebo (N = 83) a n (%) n (%) Headache 3 (3.2) 1 (1.2)
adverse reactions table
<table width="60%" cellspacing="0" cellpadding="0"><caption>Table 3: Adverse Reaction(s) with EKTERLY with Incidence ≥2% and More Common than Placebo in Patients with Hereditary Angioedema (KONFIDENT)</caption><colgroup><col width="40%"/><col width="30%"/><col width="30%"/></colgroup><tfoot><tr styleCode="First Last"><td colspan="3"><sup>a</sup>One (1) patient assigned to administer placebo actually received EKTERLY 600 mg. Safety results are presented by actual treatment received.</td></tr></tfoot><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule" rowspan="2" align="center"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">EKTERLY 600 mg (N = 93)</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">Placebo (N = 83)<sup>a</sup></content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Headache</paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph>3 (3.2)</paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph>1 (1.2)</paragraph></td></tr></tbody></table>
adverse reactions table
<table width="60%" cellspacing="0" cellpadding="0"><caption>Table 3: Adverse Reaction(s) with EKTERLY with Incidence ≥2% and More Common than Placebo in Patients with Hereditary Angioedema (KONFIDENT)</caption><colgroup><col width="40%"/><col width="30%"/><col width="30%"/></colgroup><tfoot><tr styleCode="First Last"><td colspan="3"><sup>a</sup>One (1) patient assigned to administer placebo actually received EKTERLY 600 mg. Safety results are presented by actual treatment received.</td></tr></tfoot><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule" rowspan="2" align="center"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">EKTERLY 600 mg (N = 93)</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">Placebo (N = 83)<sup>a</sup></content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Headache</paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph>3 (3.2)</paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="center" valign="top"><paragraph>1 (1.2)</paragraph></td></tr></tbody></table>