Adverse Event

Adverse Event. Means any undesirable medical occurrence in a patient or clinical investigation subject administered the Licensed Product and which does not necessarily have a causal relationship with the Licensed Product.

Adverse Event. Any adverse or unexpected event associated with the use of a Product in humans, including (a) an adverse event occurring in the course of the use of a Product in professional practice, (b) an adverse event occurring from Product overdose, whether accidental or intentional, (c) an adverse event occurring from Product withdrawal, (d) any significant failure of expected pharmacological action, or (e) any abnormal laboratory result from a sample taken from a human.

Adverse Event. Shall mean any undesirable medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment, including any variant of an adverse drug experience as those terms are defined at either 21 C.F.R. Section 312.32 or 21 C.F.R. Section 314.80 and the relevant non-FDA equivalents, whether arising in or outside of a clinical study

Adverse Event. Any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof, reasonably believed both to be serious and associated with a Study, investigation, test, use and/or marketing of Captisol® or the Licensed Product

Adverse Event. Shall mean any undesirable experience in a patient associated with, related to or could reasonably affect the OptiNose application or approval or the manufacture of the API or Finished Product hereunder.

Adverse Event. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Adverse Event. Any untoward medical occurrence in a patient administered a Product and which is not necessarily caused by the Product. An Adverse Event can therefore be any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a Product, whether or not considered related to the Product. An Adverse Event includes, but is not limited to, the following: (i) any clinically significant worsening of a pre-existing condition; (ii) an event... that has been associated with the discontinuation of the use of a Product; and (iii) any lack or loss of intended effect. View More

Adverse Event. Any adverse event associated with the use of any Product in humans, whether or not considered drug-related, including an adverse event occurring in the course of the use of a Product in professional practice, in studies, in investigations or in tests or an adverse event occurring from Product overdose (whether accidental or intentional), from Product abuse, or from Product withdrawal, as well as any toxicity, sensitivity, failure of expected pharmacological action, or laboratory abnormality... that is, or is thought by the reporter to be, serious or associated with relevant clinical signs or symptoms. View More

Adverse Event. Any undesirable event or experience associated with the use of a medicinal product, whether or not expected, including, but not limited to, an event or experience that occurs: in the course of the use of the product in professional practice; from overdose whether accidental or intentional; from abuse; from withdrawal; or from a failure of expected pharmacological or biological therapeutic action of the product.