scholarly journals The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: Results of two phase 3 studies

2018 ◽  
Vol 12 (4) ◽  
pp. 438-445 ◽  
Author(s):  
Raburn M. Mallory ◽  
Jing Yu ◽  
Sachiko Kameo ◽  
Michio Tanaka ◽  
Ki Rito ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Japanese Children ◽  
Phase 3 ◽  
Two Phase ◽  
Safety And Efficacy ◽  
Live Attenuated Influenza Vaccine

scholarly journals Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials

2015 ◽  
Vol 21 (10) ◽  
pp. 1322-1331 ◽  
Author(s):  
Andrew D Goodman ◽  
Francois Bethoux ◽  
Theodore R Brown ◽  
Randall T Schapiro ◽  
Ron Cohen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Walking Speed ◽  
Prolonged Release ◽  
Open Label ◽  
Phase 3 ◽  
Two Phase ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Maximum Exposure

Background: In Phase 3 double-blind trials (MS-F203 and MS-F204), dalfampridine extended release tablets 10 mg twice daily (dalfampridine-ER; prolonged-release fampridine in Europe; fampridine modified or sustained release elsewhere) improved walking speed relative to placebo in patients with multiple sclerosis (MS). Objectives: Evaluation of long-term safety and efficacy of dalfampridine-ER in open-label extensions (MS-F203EXT, MS-F204EXT). Methods: Patients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months. Subjects were categorized as dalfampridine-ER responders or non-responders, based on their treatment response in the double-blind parent trials that assessed T25FW. Results: We had 269 patients enter MS-F203EXT and 154 patients complete it; for a maximum exposure of 5 years. We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years. No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase. Improvements in walking speed were lost after dalfampridine-ER was discontinued in the parent trial, but returned by the 2-week assessment after re-initiation of the drug. Throughout the extensions, mean improvement in walking speed declined, but remained improved, among the double-blind responders as compared with non-responders. Conclusions: The dalfamipridine-ER safety profile was consistent with the parent trials. Although walking speed decreased over time, dalfampridine-ER responders continued to show improved walking speed, which was sustained compared with non-responders.

scholarly journals Long-term safety and efficacy of elagolix treatment in women with endometriosis-associated pain: primary results from two phase 3 extension studies

2017 ◽  
Vol 108 (3) ◽  
pp. e95-e96 ◽  
Author(s):  
E. Surrey ◽  
H.S. Taylor ◽  
L.C. Giudice ◽  
S. Singh ◽  
M.S. Abrao ◽  
...  
Keyword(s):  
Phase 3 ◽  
Two Phase ◽  
Safety And Efficacy

scholarly journals Integrated Safety and Efficacy Analysis of FMX103 1.5% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea: Results From Two Phase 3 Studies

2020 ◽  
Vol 4 (6) ◽  
pp. s92
Author(s):  
James Q Del Rosso ◽  
Linda Stein Gold ◽  
Leon Kircik ◽  
Neal Bhatia ◽  
Neil Sadick ◽  
...  
Keyword(s):  
Phase 3 ◽  
Two Phase ◽  
Safety And Efficacy ◽  
Efficacy Analysis

Abstract not available.

Safety and efficacy of live attenuated influenza vaccine in children 2–7 years of age

Vaccine ◽  
2008 ◽  
Vol 26 ◽  
pp. D10-D16 ◽  
Author(s):  
Robert B. Belshe ◽  
Christopher S. Ambrose ◽  
Tingting Yi
Keyword(s):  
Influenza Vaccine ◽  
Safety And Efficacy ◽  
Live Attenuated Influenza Vaccine

scholarly journals Integrated Safety and Efficacy Analysis of FMX103 1.5% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea: Results From Two Phase 3 Studies

2020 ◽  
Vol 4 (5) ◽  
pp. s55
Author(s):  
James Q Del Rosso ◽  
Linda Stein Gold ◽  
Leon Kircik ◽  
Neal D Bhatia ◽  
Neil Sadick ◽  
...  
Keyword(s):  
Phase 3 ◽  
Two Phase ◽  
Safety And Efficacy ◽  
Efficacy Analysis

Abstract not available.

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