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A phase I study of monohydroxyethylrutoside in healthy volunteers

✍ Scribed by Anja M. Willems; Anne M. Bruynzeel; Marc A. Kedde; Cees J. van Groeningen; Aalt Bast; Wim J. van der Vijgh

Publisher
Springer
Year
2005
Tongue
English
Weight
311 KB
Volume
57
Category
Article
ISSN
0344-5704

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Adverse events in phase one studies: a s
Adverse events in phase one studies: a study in 430 healthy volunteers
✍ M. Sibille; N. Deigat; V. Olagnier; D. Vital Durand; R. Levrat πŸ“‚ Article πŸ“… 1992 πŸ› Springer 🌐 English βš– 445 KB

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