Adverse Event

Adverse Event. Shall mean any adverse event associated with the use of any Commercial Materials or Current Materials, including an adverse event occurring in the course of the use of Commercial Materials or Current Materials in commercial practice, in studies, in investigations or in tests

Adverse Event. An event or incident that led to a death, serious injury, or serious deterioration in the state of health of a patient, user, or other person; if the incident was wholly or partially caused by the Product or by shortcomings in the information supplied with the Product.

Adverse Event. Any adverse event associated with the use of a drug product in humans, whether or not considered drug-related, including (i) an adverse event occurring in the course of the use of a drug product in professional practice; (ii) an adverse event occurring from an overdose, whether accidental or intentional, related to a drug product; (iii) an adverse event occurring from drug abuse related to a drug product; (iv) an adverse event occurring from withdrawal of a drug product; and (v) any failure of... expected pharmacological action of a drug product. View More

Adverse Event. Any undesirable medical occurrence in a patient or clinical investigation subject administered Captisol or a Licensed Product (whether or not necessarily having a causal relationship with Captisol or a Licensed Product)

Adverse Event. Any untoward medical occurrence in a patient or clinical investigation subject to whom a Pharmaceutical Product has been administered

Adverse Event. The occurrence of (x) any material diminution in the Participant's authority, duties, responsibility, or base compensation, or (y) the requirement by the Company that the Participant principally works at a location that is more than 50 miles from the Participant's principal work location immediately prior to the Change in Control 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