@article {WOLFF1939, author = {BIRTE J. WOLFF and MATTHAEUS J. WOLFF and JOHANNES E. WOLFF}, title = {Headache Reporting in Oncology Trials Depends on the Demographics of the Study Population}, volume = {35}, number = {4}, pages = {1939--1943}, year = {2021}, doi = {10.21873/invivo.12460}, publisher = {International Institute of Anticancer Research}, abstract = {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\% (+/{\textendash} 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\% +/{\textendash} SD=6.1). AEs leading to discontinuation were reported in 5\% of cohorts (+/{\textendash} SD=5.1, range=0-22.7). Conclusion: Considering covariates allows more accurate interpretation of the observed AE frequencies in cancer trials.}, issn = {0258-851X}, URL = {https://iv.iiarjournals.org/content/35/4/1939}, eprint = {https://iv.iiarjournals.org/content/35/4/1939.full.pdf}, journal = {In Vivo} }