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
โฆ LIBER โฆ
Adverse events in phase-I studies: a report in 1015 healthy volunteers
โ Scribed by M. Sibille; N. Deigat; A. Janin; S. Kirkesseli; D. Vital Durand
- Publisher
- Springer
- Year
- 1998
- Tongue
- English
- Weight
- 280 KB
- Volume
- 54
- Category
- Article
- ISSN
- 0031-6970
No coin nor oath required. For personal study only.
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## Abstract ## Background It has been proposed that objective cognitive testing provides additional information to that collected via adverse event (AE) recordings. However, in clinical trials of compounds with potentially negative effects on cognition, the results of cognitive testing may overlap
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