FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2019442032> ?p ?o ?g. }

• W2019442032 endingPage "P50" @default.
• W2019442032 startingPage "P50" @default.
• W2019442032 abstract "This randomized, double-blind, placebo-controlled, phase 3 study evaluated the safety and efficacy of Fentanyl SL Spray for the treatment of breakthrough cancer pain. Fentanyl SL Spray at doses of 100, 200, 400, 600, 800, 1200 (2x600), or 1600 (2x800) μg were available for the titration and double-blind study periods. The primary endpoint was evaluation of summed pain intensity differences at 30 minutes post treatment (SPID30). Safety was assessed throughout the study. A total of 98/130 (75%) opioid-tolerant patients that enrolled in the 21(+5)-day open-label titration study period were randomized to the 21(+5)-day double-blind period. Mean (standard deviation [SD]) age for the double-blind population was 54.1 (11.7) years. Median (range) dose of Fentanyl SL Spray in the double-blind period was 800 (100, 1600) μg. Mean (SD) SPID30 scores were 640.3 (458.8) and 399.6 (391.2) for the Fentanyl SL Spray and placebo treatments, respectively; a significant difference of 240.7 (362.9; P<.0001) was reported between treatments. Mean (SD) total pain relief at 30 minutes was significantly improved (P<.0001) in patients treated with Fentanyl SL Spray (78.3 [20.4]) versus placebo (61.0 [20.8]). Most frequently reported (≥5% of patients) adverse events (AEs) during the titration period included nausea (13.1%), somnolence (8.5%), dizziness (7.7%), vomiting (7.7%), pyrexia (6.2%), diarrhea (5.4%), and peripheral edema (5.4%). In the double-blind period, most frequently reported AEs were nausea (7.1%), hyperhidrosis (5.1%), and peripheral edema (5.1%). Three deaths were reported; 2 in the titration period and one in the double-blind period. All deaths were due to the underlying disease progression and were considered unrelated to study drug. Fentanyl SL Spray was significantly more effective at relieving breakthrough cancer pain compared with placebo. No new safety concerns were identified. Financial support for this study was provided by INSYS Therapeutics. This randomized, double-blind, placebo-controlled, phase 3 study evaluated the safety and efficacy of Fentanyl SL Spray for the treatment of breakthrough cancer pain. Fentanyl SL Spray at doses of 100, 200, 400, 600, 800, 1200 (2x600), or 1600 (2x800) μg were available for the titration and double-blind study periods. The primary endpoint was evaluation of summed pain intensity differences at 30 minutes post treatment (SPID30). Safety was assessed throughout the study. A total of 98/130 (75%) opioid-tolerant patients that enrolled in the 21(+5)-day open-label titration study period were randomized to the 21(+5)-day double-blind period. Mean (standard deviation [SD]) age for the double-blind population was 54.1 (11.7) years. Median (range) dose of Fentanyl SL Spray in the double-blind period was 800 (100, 1600) μg. Mean (SD) SPID30 scores were 640.3 (458.8) and 399.6 (391.2) for the Fentanyl SL Spray and placebo treatments, respectively; a significant difference of 240.7 (362.9; P<.0001) was reported between treatments. Mean (SD) total pain relief at 30 minutes was significantly improved (P<.0001) in patients treated with Fentanyl SL Spray (78.3 [20.4]) versus placebo (61.0 [20.8]). Most frequently reported (≥5% of patients) adverse events (AEs) during the titration period included nausea (13.1%), somnolence (8.5%), dizziness (7.7%), vomiting (7.7%), pyrexia (6.2%), diarrhea (5.4%), and peripheral edema (5.4%). In the double-blind period, most frequently reported AEs were nausea (7.1%), hyperhidrosis (5.1%), and peripheral edema (5.1%). Three deaths were reported; 2 in the titration period and one in the double-blind period. All deaths were due to the underlying disease progression and were considered unrelated to study drug. Fentanyl SL Spray was significantly more effective at relieving breakthrough cancer pain compared with placebo. No new safety concerns were identified. Financial support for this study was provided by INSYS Therapeutics." @default.
• W2019442032 created "2016-06-24" @default.
• W2019442032 creator A5011149043 @default.
• W2019442032 creator A5038320557 @default.
• W2019442032 creator A5048536513 @default.
• W2019442032 creator A5087067012 @default.
• W2019442032 creator A5087205593 @default.
• W2019442032 date "2011-04-01" @default.
• W2019442032 modified "2023-10-14" @default.
• W2019442032 title "Safety and efficacy of Fentanyl Sublingual (SL) Spray in the treatment of breakthrough cancer pain" @default.
• W2019442032 doi "https://doi.org/10.1016/j.jpain.2011.02.203" @default.
• W2019442032 hasPublicationYear "2011" @default.
• W2019442032 type Work @default.
• W2019442032 sameAs 2019442032 @default.
• W2019442032 citedByCount "2" @default.
• W2019442032 countsByYear W20194420322013 @default.
• W2019442032 countsByYear W20194420322015 @default.
• W2019442032 crossrefType "journal-article" @default.
• W2019442032 hasAuthorship W2019442032A5011149043 @default.
• W2019442032 hasAuthorship W2019442032A5038320557 @default.
• W2019442032 hasAuthorship W2019442032A5048536513 @default.
• W2019442032 hasAuthorship W2019442032A5087067012 @default.
• W2019442032 hasAuthorship W2019442032A5087205593 @default.
• W2019442032 hasBestOaLocation W20194420321 @default.
• W2019442032 hasConcept C121608353 @default.
• W2019442032 hasConcept C126322002 @default.
• W2019442032 hasConcept C141071460 @default.
• W2019442032 hasConcept C142724271 @default.
• W2019442032 hasConcept C197934379 @default.
• W2019442032 hasConcept C204787440 @default.
• W2019442032 hasConcept C27081682 @default.
• W2019442032 hasConcept C2778904085 @default.
• W2019442032 hasConcept C2779034229 @default.
• W2019442032 hasConcept C2780580376 @default.
• W2019442032 hasConcept C2780852908 @default.
• W2019442032 hasConcept C2781072394 @default.
• W2019442032 hasConcept C2908647359 @default.
• W2019442032 hasConcept C42219234 @default.
• W2019442032 hasConcept C71924100 @default.
• W2019442032 hasConcept C99454951 @default.
• W2019442032 hasConceptScore W2019442032C121608353 @default.
• W2019442032 hasConceptScore W2019442032C126322002 @default.
• W2019442032 hasConceptScore W2019442032C141071460 @default.
• W2019442032 hasConceptScore W2019442032C142724271 @default.
• W2019442032 hasConceptScore W2019442032C197934379 @default.
• W2019442032 hasConceptScore W2019442032C204787440 @default.
• W2019442032 hasConceptScore W2019442032C27081682 @default.
• W2019442032 hasConceptScore W2019442032C2778904085 @default.
• W2019442032 hasConceptScore W2019442032C2779034229 @default.
• W2019442032 hasConceptScore W2019442032C2780580376 @default.
• W2019442032 hasConceptScore W2019442032C2780852908 @default.
• W2019442032 hasConceptScore W2019442032C2781072394 @default.
• W2019442032 hasConceptScore W2019442032C2908647359 @default.
• W2019442032 hasConceptScore W2019442032C42219234 @default.
• W2019442032 hasConceptScore W2019442032C71924100 @default.
• W2019442032 hasConceptScore W2019442032C99454951 @default.
• W2019442032 hasIssue "4" @default.
• W2019442032 hasLocation W20194420321 @default.
• W2019442032 hasOpenAccess W2019442032 @default.
• W2019442032 hasPrimaryLocation W20194420321 @default.
• W2019442032 hasRelatedWork W1566699393 @default.
• W2019442032 hasRelatedWork W2110416084 @default.
• W2019442032 hasRelatedWork W2152092551 @default.
• W2019442032 hasRelatedWork W2354125488 @default.
• W2019442032 hasRelatedWork W2358448560 @default.
• W2019442032 hasRelatedWork W2362111834 @default.
• W2019442032 hasRelatedWork W2365301694 @default.
• W2019442032 hasRelatedWork W2373699540 @default.
• W2019442032 hasRelatedWork W2391373422 @default.
• W2019442032 hasRelatedWork W2954896859 @default.
• W2019442032 hasVolume "12" @default.
• W2019442032 isParatext "false" @default.
• W2019442032 isRetracted "false" @default.
• W2019442032 magId "2019442032" @default.
• W2019442032 workType "article" @default.