But Dunleavy did not file an official "unanticipated problem" report — discussing the suspected relationship between the infections and the treatment — until May this year.
In the lymphoma trial, an unanticipated problem report would likely have triggered, at minimum, a change in the informed-consent forms to let patients know that the additional CT scans were being ordered to check for treatment-related fungal infections.
If an individual agrees to have her genome sequenced, it could have implications for siblings, and genetic data may yield more information years from now that was "entirely unanticipated," the report finds.
There were no serious unanticipated ADEs reported or identified in this study.
Also, trials that have successfully coped with unanticipated difficulties should report their success stories.
Furthermore, many survivors report unanticipated fear and 'emptiness' after completing treatment, in part because they experience a relatively sharp down-turn in active medical and social support and they receive little, if any, information about what to expect following treatment completion [ 7].
There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages.
The treatment was well tolerated with no serious or unanticipated adverse events reported.
Walker et al. (1997) found that female trauma survivors who reported unanticipated distress were more likely to have past trauma exposure and have high overall distress/symptom scores [30].
No dose-related increases were observed in the incidence of AEs, and no unanticipated events were reported.
Three (20.0%) participants reported becoming burned because they were outside too long (e.g., "Accidentally stayed out too long and ran out of sunscreen"), and 1 (6.7%) each reported unanticipated sun exposure, insufficient available shade, tanning bed use, and becoming burned despite trying to seek shade.
