RT Journal Article
SR Electronic
T1 Headache Reporting in Oncology Trials Depends on the Demographics of the Study Population
JF In Vivo
JO In Vivo
FD International Institute of Anticancer Research
SP 1939
OP 1943
DO 10.21873/invivo.12460
VO 35
IS 4
A1 BIRTE J. WOLFF
A1 MATTHAEUS J. WOLFF
A1 JOHANNES E. WOLFF
YR 2021
UL http://iv.iiarjournals.org/content/35/4/1939.abstract
AB Background/Aim: The frequency of adverse events (AEs) in clinical trials without control arms is difficult to interpret. Materials and Methods: This is a systematic literature review of AEs reported from the placebo arms of randomized cancer trials in PubMed between 2008 and 2020. Results: We found 80 placebo patient cohorts in 73 publications, describing 17,968 subjects who received placebo. Headaches were reported in 35 patient cohorts with an average frequency of 12.3% (+/– SD=8.0, range=0.4-34.1), and were more common in cohorts with a median age between 45 and 50 years, with higher performance status, and breast cancer (average 29.8% +/– SD=6.1). AEs leading to discontinuation were reported in 5% of cohorts (+/– SD=5.1, range=0-22.7). Conclusion: Considering covariates allows more accurate interpretation of the observed AE frequencies in cancer trials.