Linked Life Data

1664824

Source:http://linkedlifedata.com/resource/pubmed/id/1664824

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1992-3-20
pubmed:abstractText
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. The results showed that temafloxacin was at least as safe as the comparators. Dose related gastrointestinal adverse reactions were found only in patients with reduced renal function who received a high temafloxacin dose. There was a low incidence of quinolone-related adverse reactions (photosensitivity, CNS-toxicity, or theophylline drug-drug interactions). The most common adverse reactions were gastrointestinal ones which occurred in 13.4% of the patients included in phase II and III trials. The corresponding frequencies in patients randomized to quinolone and non-quinolone comparators were 15.7% and 11.6% (P less than 0.05) [corrected], respectively. In conclusion, temafloxacin was shown to be at least as safe as the comparators used in the extensive phase I to III programme for evaluation of this new quinolone.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0305-7453
pubmed:author
pubmed:issnType
Print
pubmed:volume
28 Suppl C
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
111-9
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
1991
pubmed:articleTitle
Assessment of adverse events during drug development: experience with temafloxacin.
pubmed:affiliation
Department of Infectious Diseases, Lund University Hospital, Sweden.
pubmed:publicationType
Journal Article, Clinical Trial