RT Journal Article
SR Electronic
T1 Anemia in Placebo Arms of Cancer Studies
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 4543
OP 4548
DO 10.21873/anticanres.15266
VO 41
IS 9
A1 WOLFF, JOHANNES E.
YR 2021
UL http://ar.iiarjournals.org/content/41/9/4543.abstract
AB Background/Aim: Adverse event (AE) frequencies observed in interventional clinical trials are difficult to interpret when the placebo control is missing. Materials and Methods: Systematic literature review of AEs reported from the placebo arms of randomized cancer trials between 2008 and 2021. Imputation of missing values assuming normal distribution of hemoglobin values. Results: Anemia grade 1 or higher was reported in 46 of 100 placebo monotherapy cohorts with a mean frequency of 23.4% (SD=27%) of the enrolled patients. The reported frequency depended on the type of cancer; other demographic variables had no significant influence on anemia frequency. Conclusion: External controls for anemia in clinical trials should be disease specific.