Adverse events in phase-I studies : a report in 1015 healthy volunteers

• Published in: European journal of clinical pharmacology Vol. 54; no. 1; pp. 13 - 20
• Main Authors: SIBILLE, M, DEIGAT, N, JANIN, A, KIRKESSELI, S, DURAND, D. V
• Format: Journal Article
• Language: English
• Published: Heidelberg Springer 01.03.1998; Berlin Springer Nature B.V
• Subjects: Adult; Biological and medical sciences; Clinical trials; Clinical Trials, Phase I as Topic - methods; Clinical Trials, Phase I as Topic - statistics & numerical data; Cross-Over Studies; Double-Blind Method; Drug therapy; Drug toxicity and drugs side effects treatment; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Humans; Male; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Pharmacokinetics; Pharmacology. Drug treatments; Placebo Effect; Reference Values; Human; Drug; Maximal dose; Toxicity; Phase I trial; Tolerance; Normal; Epidemiology

This report describes all clinical, laboratory and electrocardiographical adverse events detected in healthy volunteers in a phase-I centre over a 10-year period: 54 phase-I studies are involved, including 1015 healthy young volunteers (993 males) who received 1538 treatments (23 different active dr...