Adverse events in phase one studies: a study in 430 healthy volunteers
| Autor: | D. Vital Durand, R. Levrat, V. Olagnier, N. Deigat, M. Sibille |
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| Rok vydání: | 1992 |
| Předmět: |
Male
Pharmacology Research design medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions business.industry Incidence (epidemiology) Significant difference Headache General Medicine Placebo Surgery Placebos Research Design Internal medicine Healthy volunteers Toxicity medicine Drug Evaluation Humans Pharmacology (medical) Drug Monitoring Adverse effect business Volunteer |
| Zdroj: | European Journal of Clinical Pharmacology. 42:389-393 |
| ISSN: | 1432-1041 0031-6970 |
| DOI: | 10.1007/bf00280124 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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