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Adverse events in phase one studies: a study in 430 healthy volunteers.

Authors
  • Sibille, M
  • Deigat, N
  • Olagnier, V
  • Durand, D V
  • Levrat, R
Type
Published Article
Journal
European journal of clinical pharmacology
Publication Date
Jan 01, 1992
Volume
42
Issue
4
Pages
389–393
Identifiers
PMID: 1516603
Source
Medline
License
Unknown

Abstract

All the clinical, laboratory and electrocardiographic adverse events detected during 24 Phase I studies in the same unit over a 5 y period are reported here. 430 healthy male volunteers were involved, corresponding to 5488 days of follow-up. The overall incidence of adverse events was 13.5%, with a significant difference between active drug (15.3%) and placebo (7.4%) treatments. There were 69 distinct types of adverse events. Headache was the most frequent symptom (2%). There were severe adverse events in 20 cases (0.36%), with an incidence of 20/430 per subject (4.6%). There were no deaths or life-threatening events. Although the main objective of Phase I studies is to determine the maximum dose tolerated, cause-effect relationships with adverse events are hard to establish, because of the frequency of adverse events with placebo, and because of the limited number of subjects included such studies.

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