PMID- 30209862
OWN - NLM
STAT- MEDLINE
DCOM- 20190923
LR  - 20190923
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 27
IP  - 11
DP  - 2018 Nov
TI  - Psychiatric adverse events in oseltamivir prophylaxis trials: Novel comparative 
      analysis using data obtained from clinical study reports.
PG  - 1217-1222
LID - 10.1002/pds.4651 [doi]
AB  - PURPOSE: Estimating the rate of adverse events (AEs) caused by a treatment in 
      clinical trials typically involves comparing the proportions of patients 
      experiencing AEs in intervention and control groups. However, potentially 
      important information, including duration, recurrence, and intensity of events, 
      is lost. In this study, we illustrate how the additional information can be 
      obtained and incorporated into analyses of AEs. METHODS: Data on psychiatric AEs 
      were extracted from clinical study reports (CSRs) provided by the manufacturer of 
      oseltamivir in 4 prophylaxis randomised trials in adults and adolescents. We 
      analysed the incidence, recurrence, duration, and intensity of events, using 
      logistic regression models where the outcome compared was proportion of days 
      suffering from an event, and developed novel presentation techniques. RESULTS: 
      Psychiatric AEs were generally more frequent, longer, and more intense in the 
      treatment than placebo arms. Logistic regression models confirm the apparent 
      association overall (odds ratio [OR] 3.46, 95% confidence interval [CI] 1.28 to 
      9.32), particularly for events classified as severe (OR 34.5, 95% CI 3.66 to 
      325). However, the absolute difference in proportion of days suffering from 
      severe psychiatric AEs between groups was small. CONCLUSIONS: This example 
      analysis shows evidence of a causal effect of oseltamivir on psychiatric AEs, not 
      apparent in the published versions of the same trials and a Cochrane review which 
      showed a nonsignificant 81% increased odds of experiencing a psychiatric event. 
      This unique and important finding was dependent on obtaining previously 
      unavailable data from clinical study reports and using novel analyses and 
      presentation methods.
CI  - (c) 2018 John Wiley & Sons, Ltd.
FAU - Jones, Mark
AU  - Jones M
AUID- ORCID: 0000-0001-6858-9710
AD  - School of Public Health, University of Queensland, Brisbane, Australia.
AD  - Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.
FAU - Tett, Susan E
AU  - Tett SE
AD  - School of Pharmacy, University of Queensland, Brisbane, Australia.
FAU - Del Mar, Chris
AU  - Del Mar C
AD  - Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20180912
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antiviral Agents)
RN  - 20O93L6F9H (Oseltamivir)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antibiotic Prophylaxis/*adverse effects/methods
MH  - Antiviral Agents/administration & dosage/*adverse effects
MH  - Data Interpretation, Statistical
MH  - Humans
MH  - Influenza, Human/*prevention & control
MH  - Mental Disorders/chemically induced/*epidemiology
MH  - Oseltamivir/administration & dosage/*adverse effects
MH  - Pharmacoepidemiology/methods
MH  - Randomized Controlled Trials as Topic
MH  - Young Adult
OTO - NOTNLM
OT  - adverse events
OT  - clinical trials
OT  - oseltamivir
OT  - pharmacoepidemiology
OT  - prophylaxis
EDAT- 2018/09/14 06:00
MHDA- 2019/09/24 06:00
CRDT- 2018/09/14 06:00
PHST- 2017/07/13 00:00 [received]
PHST- 2018/08/02 00:00 [revised]
PHST- 2018/08/13 00:00 [accepted]
PHST- 2018/09/14 06:00 [pubmed]
PHST- 2019/09/24 06:00 [medline]
PHST- 2018/09/14 06:00 [entrez]
AID - 10.1002/pds.4651 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2018 Nov;27(11):1217-1222. doi: 10.1002/pds.4651. 
      Epub 2018 Sep 12.