Serious adverse events
In the iCST trial a SAE was defined as an untoward occurrence, experienced by the person with dementia or their carer, which:
resulted in death
was life-threatening
required hospitalisation or prolongation of existing hospitalisation
resulted in persistent or significant disability or incapacity
is otherwise considered medically significant by the principal investigator.
In addition, any cases in which action was taken in line with the protocol with regard to alleged or suspected abuse/neglect that required protection of vulnerable adults was considered to be a SAE.
All iCST centres were asked to report any of the above instances either for the person with dementia or their carer by categorising them as below:
death
life-threatening
hospitalisation or prolongation of existing hospitalisation
persistent or significant disability or incapacity
otherwise considered medically significant by the investigator
alleged/suspected abuse/neglect, as detailed in protection of vulnerable adults protocol.
There were a total of 51 SAEs reported during the trial, all of which were reported directly to the Chief Investigator. There were 25 SAEs reported in the iCST group and 26 events reported in the TAU group. There were 10 deaths reported, of which nine were deaths of the person with dementia and one was a carer death. There were only eight deaths noted on the CONSORT flowchart as in the remaining cases participants were lost to follow-up prior to their death being reported. A total of 44 of the SAEs related to the person with dementia and the remaining seven involved the carer. None of the SAEs reported was related to the trial. Details of these events broken down by treatment allocation are provided below (). Details of types of SAEs are presented below (). For three people with dementia there were two SAEs reported, which included hospitalisation, followed by death.
Serious adverse events reported by treatment allocation
Serious adverse events reported separately for people with dementia and carers
