Safety
cancer, death, disability
ADVERSE EVENTS, CANCER, EVENTS, ADVERSE EVENT
Among all 188 participants, we identified 1 serious adverse event: 1 participant (2%) in the varenicline standard treatment group died. This death was determined to be related to stage 4 cancer and not study-related. There were no other reports of death, life threatening events, hospitalization, persistent or significant disability or incapacity. Among all participants, 9 reported moderate side effects (requiring medical evaluation or change in daily routine) (4 participants in the varenicline adaptive group; 1 participant in the varenicline standard group; 3 participants in the nicotine patch adaptive group; 1 participant in the nicotine patch standard group). When mild adverse events (requiring no medical evaluation or a change in daily routine) were included, 159 participants reported at least 1 adverse event (