scholarly journals Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: an open-label, prospective, noncomparative study

2015 ◽  
pp. 15 ◽  
Author(s):  
Ibrahim Turkoz ◽  
Huafang Li ◽  
Fan Zhang
Keyword(s):  
Paliperidone Palmitate ◽  
Efficacy And Safety ◽  
Noncomparative Study ◽  
Open Label ◽  
Asian Patients ◽  
Monthly Injection

scholarly journals Efficacy and safety of atorvastatin in South Asian patients with dyslipidemia: an open label noncomparative pilot study

2005 ◽  
Vol 1 (4) ◽  
pp. 351-356 ◽  
Author(s):  
Jeetesh V Patel ◽  
Sandeep Gupta ◽  
Frank Lie ◽  
Elizabeth A Hughes
Keyword(s):  
Pilot Study ◽  
South Asian ◽  
Efficacy And Safety ◽  
Open Label ◽  
Asian Patients

Efficacy and safety of nintedanib versus sorafenib in Asian patients with advanced hepatocellular carcinoma (HCC): A randomized phase II trial.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 339-339 ◽  
Author(s):  
Ann-Lii Cheng ◽  
Chia-Jui Yen ◽  
Tae-You Kim ◽  
Yin-Hsun Feng ◽  
Yee Chao ◽  
...  
Keyword(s):  
Growth Factor ◽  
Phase Ii ◽  
Drug Discontinuation ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Open Label ◽  
Similar Time ◽  
Advanced Hcc ◽  
Asian Patients ◽  
Patient Reported

339 Background: Nintedanib (N) is an oral, triple angiokinase inhibitor of vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF) receptors. This randomized, multicenter, open-label, Phase II study (NCT00987935; 1199.39) evaluated the efficacy and safety of N versus sorafenib (S) in Asian patients with advanced HCC. Preliminary analysis showed similar time to progression (TTP) by independent central review (ICR). Methods: Asian patients with unresectable advanced HCC, Child–Pugh score 5–6, ECOG-PS ≤2, and alanine/aspartate aminotransferase (ALT/AST) ≤2× upper limit of normal were enrolled. Patients were randomized 2:1 to N 200 mg bid or S 400 mg bid continuously in 28-day cycles, until intolerable adverse events (AEs) or disease progression (PD); treatment beyond PD was allowed if clinical benefit was perceived. Primary endpoint was TTP by ICR (RECIST 1.0) and secondary endpoints were overall survival (OS) and investigator-assessed (IA) TTP. Results: Patients (N=95) were randomized to receive N (n=63) or S (n=32); arms were balanced except for macroscopic vascular invasion (48% vs 31%). At the final cutoff date (16 Jul 14), 88% of patients had a TTP event, and 86% had an OS event; 1 patient was on treatment beyond PD. N and S had comparable IA TTP (median 2.8 vs 3.0 months; HR 1.39 [95% CI: 0.87–2.23]) and OS (median 10.2 vs 10.7 months; HR 0.94 [95% CI: 0.59–1.49]). ICR TTP data are pending. All but 1 patient reported an AE (CTCAE 3.0). More S-treated patients had Grade ≥3 AEs (56% vs 84%), serious AEs (46% vs 56%), and AEs leading to dose reduction (19% vs 59%) and drug discontinuation (24% vs 34%). Class-specific AEs of tyrosine kinase inhibitors in >15% of S-treated patients were hypertension, hand-foot skin reaction, and thrombocytopenia; only anemia was higher with N. AEs previously observed and higher with N were vomiting and nausea; ALT/AST increases and diarrhea were higher with S. Rash was reported in >15% of patients only with S. Conclusions: N shows similar efficacy to S for TTP and OS. N was better tolerated than S and AEs were generally manageable. Further studies of N in Asian patients with advanced HCC are warranted. Clinical trial information: NCT00987935.

scholarly journals Efficacy and safety of topical halometasone in eczematous dermatoses in Indian population: An open label, noncomparative study

2011 ◽  
Vol 56 (6) ◽  
pp. 652 ◽  
Author(s):  
Binny Krishnankutty ◽  
Dennis Thomas ◽  
AS Kumar ◽  
HV Nataraja ◽  
D V S Pratap ◽  
...  
Keyword(s):  
Indian Population ◽  
Efficacy And Safety ◽  
Noncomparative Study ◽  
Open Label
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