BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin

The data obtained will more clearly define the absolute risk (incidence rates) of hypersensitivity/allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients that are treated with BAT® due to a confirmed or suspected case of botulism.

Reactions that may occur shortly after exposure to BAT® and can include, but are not limited to, urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, or tachycardia.

Severe form of acute, severe hypersensitivity reaction with multiorgan system involvement that occurs with sudden onset after exposure to an allergen. Case definition of anaphylaxis requires a sudden onset and rapid progression of signs and symptoms and involvement of multiple (≥ 2) organ systems (cardiovascular, dermatological or respiratory).

This includes symptoms such as, but not limited to, fever, urticarial or maculopapular rash, myalgia, arthralgia, and lymphadenopathy occurring 10-21 days after BAT® infusion.

Infusion reactions are unexpected reactions that cannot be explained by the known toxicity profile of the drug. Infusion reactions are the result of the infusion process (rate, volume, etc.) and are often referred to as "hypersensitivity reactions" as well. In the absence of an allergic component, the term "infusion reaction" is preferred. Infusion reactions may affect any organ system in the body. Most are mild in severity, although severe and fatal reactions may occur. The most common signs and symptoms may include, but are not limited to flushing, itching, alterations in heart rate and blood pressure, dyspnea or chest discomfort, back or abdominal pain, fever and/or shaking chills (rigors), nausea, vomiting, and/or diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness and/or syncope.

Febrile reaction is an absolute temperature > 38.1°C or an increase in temperature >1°C above baseline temperature that occurs during or within 1 hour of BAT® infusion and is unrelated to the underlying illness.

A state requiring pharmacologic or mechanical support to maintain a normal blood pressure or adequate cardiac output.

Bradycardia is defined as an abnormally slow heart rate; usually <60 beats per minute in adults.