Suspected Adverse Reaction definition

Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the drug caused the event. “Reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the adverse event.

Suspected Adverse Reaction means any Adverse Event for which there is a reasonable possibility that the drug caused the Adverse Event. For the purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the adverse event. Suspected Adverse Reaction is further defined in 21 C.F.R. 312.32.

Suspected Adverse Reaction or “SAR” means an Adverse Event associated with the use of the Test Article pursuant to Section 21 C.F.R. Part 312.32.

Examples of Suspected Adverse Reaction in a sentence

• Suspected Adverse Reaction: Any adverse event for which there is a reasonable possibility that the drug caused the adverse event.

• Life-Threatening Adverse Event Or Life-Threatening Suspected Adverse Reaction: An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death.

• An Unexpected Adverse Event or Unexpected Suspected Adverse Reaction is an adverse event or suspected adverse reaction that is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.

• Adverse reactions are a subset of all suspected adverse reactions for which there is reason to conclude that the drug caused the event.Definition of Suspected Adverse Reaction: Any AE for which there is a reasonable possibility that the drug caused the AE.

• Suspected Adverse Reactions (SARs) A Suspected Adverse Reaction (SAR) is a harmful and unintended reaction which may be due to exposure to a veterinary medicine administered to an animal at its normal dose.

More Definitions of Suspected Adverse Reaction

Suspected Adverse Reaction means the definition as stated in the Protocol.”]

Suspected Adverse Reaction or “SAR” means any Adverse Event for which there is a reasonable possibility that the drug caused the Adverse Event. For the purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the Adverse Event. Suspected Adverse Reaction implies a lesser degree of certainty about causality than adverse reaction, which means any Adverse Event caused by a drug (21 CFR 312.32(a)).

Suspected Adverse Reaction means an Adverse Reaction from which either the reporter or Xxxxxxx believes there is at least a reasonable possibility of there being a causal relationship between the Adverse Reaction and the IMP in question.

Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the IP caused the AE. “Reasonable possibility” means there is evidence to suggest a causal relationship between the IP and the AE. Types of evidence that would suggest a causal relationship between the IP and the AE include: a single occurrence of an event that is uncommon and known to be strongly associated with IP exposure (e.g. angioedema, hepatic injury, Stevens-Johnson Syndrome); one or more occurrences of an event that is not commonly associated with IP exposure, but is otherwise uncommon in the population exposed to the IP (e.g. tendon rupture); an aggregate analysis of specific events observed in a clinical trial (such as known consequences of the underlying disease or condition under investigation or other events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the IP-treatment group than in a concurrent or historical control group.

Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the study drug caused the AE. “Reasonable possibility” means there is evidence to suggest a causal relationship between the study drug and the AE. Types of evidence that would suggest a causal relationship between the study drug and the AE include: a single occurrence of an event that is uncommon and known to be strongly associated with drug exposure (e.g. angioedema, hepatic injury, Stevens-Johnson Syndrome); one or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug (e.g. tendon rupture); an aggregate analysis of specific events observed in a clinical trial (such as known consequences of the underlying disease or condition under investigation or other events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group.

Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the IP caused the AE. “Reasonable possibility” means there is evidence to suggest a causal relationship between the IP and the AE. Types of evidence that would suggest a causal relationship between the IP and the AE include: a single occurrence of an event that is uncommon and known to be strongly associated with IP exposure (e.g., angioedema, hepatic injury, Stevens-Johnson Syndrome); one or more occurrences of an event that is not commonly

Suspected Adverse Reaction. (SAR) means any AE for which there is a reasonable possibility that the drug caused the AE. For purposes of IND safety reporting, "reasonable possibility" means there is evidence to suggest a causal relationship between the drug and the AE. “Suspected adverse reaction” implies a lesser degree of certainty about causality than “adverse reaction”, which means any AE caused by a drug.