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Hi 

We are looking for some help in modelling adverse event data. We
have data from a clinical trial in which subjects (80) were given a
dose of drug twice a day for 6 days. A parallel dose-ranging design
was used (including a placebo group): each subject only received one
dose level. Subjects spontaneously reported a particular adverse
event (that is they were not interrogated) and the time and duration
of the event was recorded. Over 50% of the subjects reported no
adverse events and the others reported between 1 and 8 events. There
appears to be a dose-effect relationship in that most of the
subjects reporting no event were on the lower doses.

We would like to model the probability of adverse event as a function 
of dose and eventually drug blood concentration. We would appreciate 
any suggestions, particularly from people who have modelled analogous 
data.

Thanking you in advance
Leon Aarons



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Leon Aarons
School of Pharmacy and Pharmaceutical Sciences
University of Manchester
Manchester, M13 9PL, U.K.
tel +44-161-275-2357
fax +44-161-275-2396
email [log in to unmask]


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