scholarly journals Efficacy and safety of sofosbuvir–velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial

2018 ◽  
Vol 54 (1) ◽  
pp. 87-95 ◽  
Author(s):  
Tetsuo Takehara ◽  
Naoya Sakamoto ◽  
Shuhei Nishiguchi ◽  
Fusao Ikeda ◽  
Tomohide Tatsumi ◽  
...  
Keyword(s):  
Japanese Patients ◽  
Decompensated Cirrhosis ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Phase

scholarly journals Efficacy and safety of secukinumab in Japanese patients with active ankylosing spondylitis: 24-week results from an open-label phase 3 study (MEASURE 2-J)

2019 ◽  
Vol 30 (1) ◽  
pp. 132-140 ◽  
Author(s):  
Mitsumasa Kishimoto ◽  
Atsuo Taniguchi ◽  
Ayako Fujishige ◽  
Shuhei Kaneko ◽  
Sibylle Haemmerle ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Phase

scholarly journals Nivolumab versus chemotherapy in Japanese patients with advanced esophageal squamous cell carcinoma: a subgroup analysis of a multicenter, randomized, open-label, phase 3 trial (ATTRACTION-3)

Esophagus ◽  
2020 ◽  
Author(s):  
Masanobu Takahashi ◽  
Ken Kato ◽  
Morihito Okada ◽  
Keisho Chin ◽  
Shigenori Kadowaki ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Group Versus ◽  
Japanese Patients ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Chemotherapy Group ◽  
Open Label Phase

Abstract Background The efficacy and safety of nivolumab versus chemotherapy was evaluated in the Japanese subpopulation from the overall intent-to-treat (ITT) population of the ATTRACTION-3 trial conducted in patients with advanced esophageal squamous cell carcinoma (ESCC) as second-line treatment. Methods Data from Japanese patients enrolled in the multicenter, randomized, open-label, phase 3 ATTRACTION-3 trial were analyzed. The primary endpoint was overall survival (OS). Secondary endpoints included duration of response (DOR), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory subgroup analyses evaluated the association between OS and stratification factors/baseline variables. Results Overall, 274 (nivolumab, 136; chemotherapy, 138) of the 419 patients in ATTRACTION-3 were enrolled from Japan: response-evaluable population (107; 108) and safety population (135; 138). OS tended to be longer in the nivolumab group versus the chemotherapy group (median: 13.4 months vs. 9.4 months; HR, 0.77; 95% CI 0.59–1.01). Median DOR was longer in the nivolumab group (7.6 months) versus the chemotherapy group (3.6 months). ORRs were similar between the nivolumab [22.4% of patients (24/107)] and chemotherapy groups [22.2% (24/108); odds ratio, 0.98; 95% CI 0.52–1.87]. DCR was lower in the nivolumab group [41.1% (44/107)] versus the chemotherapy group [66.7% (72/108)]. OS in the exploratory analysis consistently favored the nivolumab group versus the chemotherapy group. Overall, nivolumab demonstrated favorable efficacy and safety versus chemotherapy in the Japanese subpopulation, and the trend was similar to that observed in the overall ATTRACTION-3 ITT population. Conclusion Nivolumab represents a new standard second-line treatment option for Japanese patients with advanced ESCC.

Efficacy and safety of dolutegravir–rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies

2019 ◽  
Vol 6 (9) ◽  
pp. e576-e587 ◽  
Author(s):  
Michael Aboud ◽  
Chloe Orkin ◽  
Daniel Podzamczer ◽  
Johannes R Bogner ◽  
David Baker ◽  
...  
Keyword(s):  
Virological Suppression ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Phase ◽  
Hiv 1
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