Unlikely. Any or all of the foregoing conditions may be waived by the Operating Partnership in its sole and absolute discretion.
Unlikely the relationship with the use of the device seems not relevant and/or the event can be reasonably explained by another cause, but additional information may be obtained.
Unlikely. This category applies to those AEs that are judged to be unrelated to the test product, but for which no extraneous cause may be found. An AE may be considered unlikely to be related to study product if or when it meets 2 of the following criteria: (1) it does not follow a reasonable temporal sequence from administration of the test product; (2) it could readily have been produced by the subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the subject; (3) it does not follow a known pattern of response to the test product; or (4) it does not reappear or worsen when the product is re-administered. POSSIBLY: This category applies to those AEs for which a connection with the test drug administration appears unlikely but cannot be ruled out with certainty. An AE may be considered possibly related if or when it meets 2 of the following criteria: (1) it follows a reasonable temporal sequence from administration of the product; (2) it could not readily have been produced by the subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the subject; or (3) it follows a known pattern of response to the test product. PROBABLY: This category applies to those AEs that the investigator feels with a high degree of certainty are related to the test product. An AE may be considered probably related if or when it meets 3 of the following criteria: (1) it follows a reasonable temporal sequence from administration of the product; (2) it could not be reasonably explained by the known characteristics of the subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the subject; (3) it disappears or decreases on cessation or reduction in dose (note that there are exceptions when an AE does not disappear upon discontinuation of the product, yet product-relatedness clearly exists; for example, as in bone marrow depression, fixed drug eruptions, or tardive dyskinesia); or (4) it follows a known pattern of response to the test product.
Unlikely. The event is doubtfully related to the investigational agent(s). The event was most likely related to other factors such as the participant’s clinical state, other therapeutic interventions, or concomitant drugs. ● Possible – The event follows a reasonable temporal sequence from the time of drug administration, but could have been produced by other factors such as the participant’s clinical state, other therapeutic interventions, or concomitant drugs.
Unlikely. The event is most likely related to an etiology other than the drug. Not related: A reaction on which sufficient information exists to indicate that the etiology is unrelated to the product. Not assessable: Causality is not assessable, e.g. because of insufficient evidence, conflicting data or poor documentation. Safety Actions: Any possible safety actions related to the product -as for example: changes to the SPC communications with regulatory authorities or the medical profession shall be send to Licensor in a timely manner for information. If specific safety measures are to be taken, the Licensee shall ensure the implementation of such in the territory.
Unlikely. (please tick as appropriate) 1h. The patient/parent is to be supplied with the following information:
