1 – Signal detection using a time-to-onset analysis
Karimi G, Star K, Hägg S, Norén GN. Time-to-onset in spontaneous reports: the possibility to detect the unexpected. Pharmacoepidemiol Drug Saf. 2013; 22(5): 556-7. doi: 10.1002/pds.3397.
van Holle L, Bauchau V. Signal detection on spontaneous reports of adverse events following immunisation: a comparison of the performance of a disproportionality-based algorithm and a time-to-onset-based algorithm. Pharmacoepidemiol Drug Saf. 2014; 23(2): 178-85. doi: 10.1002/pds.3502.
Scholl JH, van Puijenbroek EP. The value of time-to-onset in statistical signal detection of adverse drug reactions: a comparison with disproportionality analysis in spontaneous reports from the Netherlands. Pharmacoepidemiol Drug Saf. 2016; 25(12): 1361-1367. doi: 10.1002/pds.4115.
Zhang T, Ye X, Guo X, Wu G, Hou Y, Xu J, Shi W, Zhu T, Zhang Y, Zhang X, Song J, He J. Signal Detection Based on Time to Onset Algorithm in Spontaneous Reporting System of China. Drug Saf. 2017; 40(4): 343-350. doi: 10.1007/s40264-016-0503-0.
Scholl JHG, van Hunsel FPAM, Hak E, van Puijenbroek EP. Time to onset in statistical signal detection revisited: A follow-up study in long-term onset adverse drug reactions. Pharmacoepidemiol Drug Saf. 2019; 28(10): 1283-1289. doi: 10.1002/pds.4790.
Noguchi Y, Tachi T, Teramachi H. Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source. Brief Bioinform. 2021; 22(6): bbab347. doi: 10.1093/bib/bbab347.
2 – Weibull analysis of time-to-onset in ICSR database
Yamada M, Handa J, 2. Comparison of the Onset Time Profile among the Interferon Formulations in Adverse Drug Reaction of Suicide- or Diabetes-Related, Jpn J Pharmacoepidemiol. 2014; 19(1): 23-30. doi: 10.3820/jjpe.19.23. (Japanese only)
Leroy F, Dauxois JY, Théophile H, Haramburu F, Tubert-Bitter P. Estimating time-to-onset of adverse drug reactions from spontaneous reporting databases. BMC Med Res Methodol. 2014; 14: 17. doi: 10.1186/1471-2288-14-17.
Ogura T, Shiraishi C. Parameter estimation of Weibull distribution for the number of days between drug administration and early onset adverse event. J Biopharm Stat. 2023; 33(3): 386-399. doi: 10.1080/10543406.2022.2154940.
Alligon M, Mahlaoui N, Bouaziz O. Pitfalls in time-to-event analysis of registry data: a tutorial based on simulated and real cases. Front Epidemiol. 2024; 4: 1386922. doi: 10.3389/fepid.2024.