In this part of the CRF, it is possible to classify unexpected events in groups of "relatedness" to the antimicrobial treatment as "no relation", "unlikely relation", "possibly related", "probably related" or "definitely related.
This Complication Review Board decides also if the complication is related to the operative procedure, as expressed by the following statements: not related, unlikely related, possibly related, probably related or definitely related.
AE were attributed as unrelated, unlikely related, possibly related, probably related, or definitely related to the study medication in the opinion of the investigators and as adjudicated by the Data Safety Monitoring Board (DSMB).
We found that the matter of "sharing" (material and/or data) was either presented in relation to secondary use (19/26), not definitely related to secondary use (2/26), or, still, not related to secondary use (5/26) (Table 2a).
Only 5.4% of AEs were considered to be likely related and none were considered to be definitely related to the study medication.
Pain and aggression are definitely related, whether on a chronic or acute basis, but this relation may well be underestimated in cases of chronic pain.
Related AEs were defined as those possibly, probably or definitely related to the study drug, with missing relationships presumed related.
Treatment related Serious Adverse Events (SAE) considered possibly, probably or definitely related to treatment, will be determined.
Twelve subjects experienced triptan-related TEAEs that were considered by the investigator to be definitely related to study medication.
