Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up

Vaccine ◽  
2019 ◽  
Vol 37 (6) ◽  
pp. 889-897 ◽  
Author(s):  
Wen Chen ◽  
Yun Zhao ◽  
Xing Xie ◽  
Jihong Liu ◽  
Jingran Li ◽  
...  
CJEM ◽  
2006 ◽  
Vol 8 (06) ◽  
pp. 393-400 ◽  
Author(s):  
Eric Y. Baden ◽  
Curtis J. Hunter

ABSTRACTObjective:To evaluate whether the addition of intravenous (IV) dexamethasone to standard emergency department (ED) benign headache therapy would reduce the incidence of headache recurrence at 48–72 hours.Methods:This randomized, double-blind, placebo-controlled clinical trial of adult patients presenting with the chief complaint of headache was conducted in the ED of 2 academic, urban Level 1 hospitals. Headache evaluation and therapy were determined by the treating physician, and, before discharge, patients were administered either 10 mg of IV dexamethasone or placebo. The treatment groups had similar baseline characteristics, abortive therapy, IV fluids and degree of pain relief achieved before discharge. Patients were contacted 48–72 hours following discharge and asked whether their headache was “better,” “worse” or “remained unchanged” when compared with their symptoms at discharge. Those whose headaches were “worse” or “unchanged,” and those who reported a return of headache after being pain free at discharge were considered to be treatment failures and classified as having had a recurrence. The patient's headache at follow-up was further categorized as severe (i.e., provoking another physician visit or interfering with daily activity) or mild (i.e., requiring self-medication or no treatment).Results:Fifty-seven patients met the inclusion criteria and 2 were lost to follow-up, leaving 55 for analysis. At follow-up, 9.7% (3/31) of those receiving dexamethasone had headache recurrence, versus 58.3% (14/24) of those receiving placebo (p< 0.001). Four dexamethasone recipients (12.9%) had severe headaches at follow-up compared with 8 (33.3%) in the placebo group (p= 0.14).Conclusions:In this study, IV dexamethasone reduced headache recurrence at 48–72-hour follow-up. Given its excellent safety profile and likely benefit, IV dexamethasone should be considered for ED headache patients after standard evaluation and therapy.


2018 ◽  
Vol 46 (10) ◽  
pp. 4050-4060 ◽  
Author(s):  
Victoria Montoro ◽  
Carlos Asensio ◽  
Ángel Martínez ◽  
Juan Lorente ◽  
Francisco J. Rodríguez ◽  
...  

Objectives To assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema. Methods In this multicentre, randomized, double-blind, parallel-group phase 3 clinical trial, conducted at 12 Spanish centres between March 2012 and March 2013, patients received fluocinolone acetonide 0.025% or placebo otic solution twice daily for 7 days (days 1–7) with an 8-day follow-up (days 9–15). Outcome measures included change in itching from baseline (day 1) to study days 4–8 and 9–15, and change in otoscopic signs (erythema, oedema, and scaling) from baseline to the end of treatment (day 8) and end of follow-up (day 15). Results Patients treated with fluocinolone acetonide 0.025% (n = 66), as compared with placebo-treated patients (n = 69), showed significantly higher reductions in itching from baseline to study days 4–8 and 9–15, and in individual and global otoscopic signs from baseline to the end of treatment (day 8) and end of follow-up (day 15). Incidence and severity of adverse events was similar between the fluocinolone and placebo groups. Conclusions Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.


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