Assessment of adverse events during drug development: experience with temafloxacin

The safety of temafloxacin was evaluated in 753 subjects in phase I trials and in 2602 patients included in phase II and III studies. Comparative treatment was given to 153 subjects in phase I who received placebo and to 2031 patients in phase II and III trials who were given other quinolones (n=1169) or non-quinolone comparators (n=862). Adverse events were collated by spontaneous reporting by the patients or observations by investigators and, additionally in some studies, by the use of diary cards filled in by the patients