Blood Disease Clinical Trial
To quantify the role of drugs and other factors in the etiology of agranulocytosis and aplastic anemia.
BACKGROUND:
Agranulocytosis and aplastic anemia are rare but serious blood diseases that can be caused
by drugs and other environmental factors. In 1980, there were only limited quantitative
estimates of the risk between various exposures, particularly drugs, and the two dyscrasias.
The data were collected in the IAAAS, a multicenter population-based case-control study
conducted from 1980 to 1986 in eight regions. The study was funded by a pharmaceutical
company to investigate a single hypothesis, but information was obtained on all drugs and on
other factors, enabling a general investigation of the dyscrasias.
DESIGN NARRATIVE:
The study was for retrospective data analysis only. Standard case-control methods were used.
In most instances, multivariate analysis was used to control confounding, especially by
simultaneous use of other causal drugs. Adverse effects and the relative safety of drugs in
relation to the two dyscrasias were documented. Because the IAAAS was population-based,
incidence rates were provided directly, and excess risks were estimated for associated
drugs. Such quantitative measures of association were generally unavailable. Among the drugs
that were analyzed were various categories such as psychotropics, antihistamines, and
cardiovascular drugs, and individual drugs such as allopurinol. Factors other than drugs
were also evaluated, including exposure to radiation and chemicals such as benzene and
insecticides, history of viral infection, and history of allergy and other conditions.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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