Sökning: onr:"swepub:oai:DiVA.org:uu-374658" >
Characterization of...
Characterization of cardiovascular clinical events and impact of event adjudication on the treatment effect of darapladib versus placebo in patients with stable coronary heart disease : Insights from the STABILITY trial
-
- Held, Claes, 1956- (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi
-
White, Harvey D. (författare)
-
Stewart, Ralph A. H. (författare)
-
visa fler...
-
Davies, Richard (författare)
-
Sampson, Shani (författare)
-
Chiswell, Karen (författare)
-
Silverstein, Adam (författare)
-
Lopes, Renato D. (författare)
-
- Heldestad, Ulrika (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)
-
Budaj, Andrzej (författare)
-
Mahaffey, Kenneth W. (författare)
-
- Wallentin, Lars, 1943- (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi
-
visa färre...
-
(creator_code:org_t)
- Elsevier, 2019
- 2019
- Engelska.
-
Ingår i: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 208, s. 65-73
- Relaterad länk:
-
https://doi.org/10.1...
-
visa fler...
-
https://uu.diva-port... (primary) (Raw object)
-
https://doi.org/10.1...
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
visa färre...
Abstract
Ämnesord
Stäng
- BACKGROUND: Clinical Endpoint Classification (CEC) in clinical trials allows FOR standardized, systematic, blinded, and unbiased adjudication of investigator-reported events. We quantified the agreement rates in the STABILITY trial on 15,828 patients with stable coronary heart disease.METHODS: Investigators were instructed to report all potential events. Each reported event was reviewed independently by 2 reviewers according to prespecified processes and prespecified end point definitions. Concordance between reported and adjudicated cardiovascular (CV) events was evaluated, as well as event classification influence on final study results.RESULTS: In total, CEC reviewed 7,096 events: 1,064 deaths (696 CV deaths), 958 myocardial infarctions (MI), 433 strokes, 182 transient ischemic attacks, 2,052 coronary revascularizations, 1,407 hospitalizations for unstable angina, and 967 hospitalizations for heart failure. In total, 71.8% events were confirmed by CEC. Concordance was high (>80%) for cause of death and nonfatal MI and lower for hospitalization for unstable angina (25%) and heart failure (50%). For the primary outcome (composite of CV death, MI, and stroke), investigators reported 2,086 events with 82.5% confirmed by CEC. The STABILITY trial treatment effect of darapladib versus placebo on the primary outcome was consistent using investigator-reported events (hazard ratio 0.96 [95% CI 0.87-1.06]) or adjudicated events (hazard ratio 0.94 [95% CI 0.85-1.03]).CONCLUSIONS: The primary outcome results of the STABILITY trial were consistent whether using investigator-reported or CEC-adjudicated events. The proportion of investigator-reported events confirmed by CEC varied by type of event. These results should help improve event identification in clinical trials to optimize ascertainment and adjudication.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Held, Claes, 195 ...
-
White, Harvey D.
-
Stewart, Ralph A ...
-
Davies, Richard
-
Sampson, Shani
-
Chiswell, Karen
-
visa fler...
-
Silverstein, Ada ...
-
Lopes, Renato D.
-
Heldestad, Ulrik ...
-
Budaj, Andrzej
-
Mahaffey, Kennet ...
-
Wallentin, Lars, ...
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Kardiologi
- Artiklar i publikationen
-
American Heart J ...
- Av lärosätet
-
Uppsala universitet