Adverse events
dizziness, presyncope
EVENTS
There were a total of 11 PEAEs reported by 10 participants (31.3%) during the study, none of which were serious or severe and were all classed as mild or moderate events. The majority of PEAEs (six participants, 18.8%) had no reasonable possible relationship to product use. Four participants (12.5%) reported PEAEs considered to have a reasonable possible relationship to product use (one occurrence of mild dizziness and three occurrences of mild presyncope), all of which were completely resolved. It was notable that the presyncope and dizziness related events tended to occur following the fixed puffing regimen e-cigarette use. One participant was withdrawn from the study because of moderate presyncope related to blood sampling, which was completely resolved, and which was not considered to be of reasonable possible relationship to product use.