<?xml version='1.0' encoding='UTF-8'?><xml><records><record><source-app name="HighWire" version="7.x">Drupal-HighWire</source-app><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">WOLFF, JOHANNES E.</style></author><author><style face="normal" font="default" size="100%">WOLFF, BIRTE J.</style></author><author><style face="normal" font="default" size="100%">THIELEN, MARCEAL M.</style></author><author><style face="normal" font="default" size="100%">HAUCH, HOLGER</style></author></authors><secondary-authors></secondary-authors></contributors><titles><title><style face="normal" font="default" size="100%">Adverse Events in Placebo Arms of Cancer Trials</style></title><secondary-title><style face="normal" font="default" size="100%">Anticancer Research</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2022-06-01 00:00:00</style></date></pub-dates></dates><pages><style  face="normal" font="default" size="100%">2805-2812</style></pages><doi><style  face="normal" font="default" size="100%">10.21873/anticanres.15761</style></doi><volume><style face="normal" font="default" size="100%">42</style></volume><issue><style face="normal" font="default" size="100%">6</style></issue><abstract><style  face="normal" font="default" size="100%">Background/Aim: Adverse events (AEs) in cancer trials may be caused by the investigational agents or the underlying disease. Determining the causality is challenging, especially in early cancer drug development when a control arm is lacking. Materials and Methods: We carried out a systematic literature review of AE frequencies in placebo arms of randomized trials for malignant solid tumors and hematologic malignancies reported in PubMed from 2016 to January 2022. Results: Among 148 placebo arms, the AEs with the highest reported mean frequencies among all publications were: Fatigue (20.1%), nausea (16.3%), diarrhea (14.3%), abdominal pain (12.4%), and anemia (10.9%); AEs resulting in drug discontinuation were reported in 5.6% of placebo-treated patients and serious AEs in 18.7% of placebo patients. Conclusion: The data presented here may be used as a benchmark to help assess drug causality in early development cancer studies without a control arm.</style></abstract></record></records></xml>