PMID- 34182466
OWN - NLM
STAT- MEDLINE
DCOM- 20210630
LR  - 20210728
IS  - 1791-7549 (Electronic)
IS  - 0258-851X (Print)
IS  - 0258-851X (Linking)
VI  - 35
IP  - 4
DP  - 2021 Jul-Aug
TI  - Headache Reporting in Oncology Trials Depends on the Demographics of the Study 
      Population.
PG  - 1939-1943
LID - 10.21873/invivo.12460 [doi]
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.
CI  - Copyright (c) 2021 International Institute of Anticancer Research (Dr. George J. 
      Delinasios), All rights reserved.
FAU - Wolff, Birte J
AU  - Wolff BJ
AD  - Swedish Covenant Hospital Department of Gynecology, Chicago, IL, U.S.A.
FAU - Wolff, Matthaeus J
AU  - Wolff MJ
AD  - Bellevue, WA, U.S.A.
FAU - Wolff, Johannes E
AU  - Wolff JE
AD  - Wauconda, IL, U.S.A. johannesewolff@gmail.com.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
PL  - Greece
TA  - In Vivo
JT  - In vivo (Athens, Greece)
JID - 8806809
SB  - IM
MH  - Demography
MH  - Headache/epidemiology
MH  - Humans
MH  - Middle Aged
MH  - *Neoplasms/drug therapy/epidemiology
PMC - PMC8286522
OTO - NOTNLM
OT  - Meta-analysis
OT  - adverse events
OT  - cancer
OT  - placebo
OT  - review
OT  - systematic review
COIS- The Authors have no conflicts of interest to declare regarding this study. JW is 
      an employee of AbbVie; MW is an employee of Microsoft. However, this project was 
      not part of the employments.
EDAT- 2021/06/29 06:00
MHDA- 2021/07/01 06:00
PMCR- 2021/07/03
CRDT- 2021/06/28 20:31
PHST- 2021/03/20 00:00 [received]
PHST- 2021/04/20 00:00 [revised]
PHST- 2021/04/26 00:00 [accepted]
PHST- 2021/06/28 20:31 [entrez]
PHST- 2021/06/29 06:00 [pubmed]
PHST- 2021/07/01 06:00 [medline]
PHST- 2021/07/03 00:00 [pmc-release]
AID - 35/4/1939 [pii]
AID - 10.21873/invivo.12460 [doi]
PST - ppublish
SO  - In Vivo. 2021 Jul-Aug;35(4):1939-1943. doi: 10.21873/invivo.12460.