PT  - JOURNAL ARTICLE
AU  - BIRTE J. WOLFF
AU  - MATTHAEUS J. WOLFF
AU  - JOHANNES E. WOLFF
TI  - Headache Reporting in Oncology Trials Depends on the Demographics of the Study Population
AID  - 10.21873/invivo.12460
DP  - 2021 Jul 01
TA  - In Vivo
PG  - 1939--1943
VI  - 35
IP  - 4
4099  - http://iv.iiarjournals.org/content/35/4/1939.short
4100  - http://iv.iiarjournals.org/content/35/4/1939.full
SO  - In Vivo2021 Jul 01; 35
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.