Possibly Related means there is a reasonable possibility that the incident, experience, or outcome could have been caused by the procedures involved in the research); and
Possibly Related. This category applies to an AE that follows a reasonable temporal sequence from administration of the study drug and that follows a known or expected response pattern to the suspected study drug, but that could readily have been produced by a number of other factors.
Possibly Related. An adverse event that may be attributed to use of the study device (LiquiBand FIX8® or AbsorbaTack™). The event follows a reasonable temporal sequence related to treatment by the device, follows a known or suspected response pattern and a plausible alternative etiology cannot be identified. • Unrelated to Device: An event for which an alternative explanation is conclusively identified, e.g, concomitant medication(s), concomitant disease(s), and/or the relationship in time suggests that a causal relationship to device is highly unlikely. Study Procedure Related is an adverse event directly related to a study procedure which cannot be directly attributed to any particular device component.
Examples of Possibly Related in a sentence
Possibly Related: A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug.
Possibly Related A reasonable relationship exists between the device/procedure and an adverse event, but the causal relationship is unclear or lacking.
More Definitions of Possibly Related
Possibly Related. The administration of the investigational product and AE are considered reasonably related in time and the AE could be explained by causes other than exposure to the investigational product.
Possibly Related. The event follows a reasonable, temporal sequence from the time of study medication administration and/or follows a known response pattern to the study medication, but could have been produced by other factors such as the subject’s clinical state, therapeutic interventions or concomitant therapy administered to the subject. • Related: The event follows a reasonable, temporal sequence from the time of study medication administration and/or follows a known response pattern to the study medication and cannot be reasonably explained by other factors such as subject’s clinical state, therapeutic interventions or concomitant therapy administered to the subject, and either occurs immediately following study medication administration, or improves on stopping the study medication, or reappears on repeat exposure, or there is a positive reaction at the application site.
Possibly Related. This relationship suggests that treatment with the study drug caused or contributed to the AE. That is, the event follows a reasonable temporal sequence from the time of study drug administration, and/or, follows a known response pattern to the study drug, but could have been produced by other factors.
Possibly Related means there is a reasonable possibility that the incident, experience, or outcome may have been associated with the procedures involved in the research. Reasonable possibility means that the event is more likely than not related to participation in the research or, in other words, there is a >50% likelihood that the event is related to the research procedures.
Possibly Related means, for adverse event reporting purposes in a Clinical Trial, that the adverse event is reasonably likely to relate to the investigational agent(s)/intervention.