Safety and Efficacy of the Endoscopic Delivery of Capsule Endoscopes in Adult and Pediatric Patients: A Multicenter Japanese Study (Advance‐J Study)

2021 ◽  
Author(s):  
Naoki Ohmiya ◽  
Shiro Oka ◽  
Yoshiko Nakayama ◽  
Itaru Iwama ◽  
Masanao Nakamura ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Japanese Study ◽  
Safety And Efficacy ◽  
Capsule Endoscopes

scholarly journals All-case Japanese post-marketing surveillance of the real-world safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome

2021 ◽  
Author(s):  
Mana Kobayashi ◽  
Yutaro Kageyama ◽  
Takashi Ando ◽  
Junko Sakamoto ◽  
Shohji Kimura
Keyword(s):  
Nephrotic Syndrome ◽  
Standard Deviation ◽  
Real World ◽  
Pediatric Patients ◽  
Safety And Efficacy ◽  
The Real ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Refractory Nephrotic Syndrome ◽  
Observation Period

Abstract Background Rituximab is conditionally approved in Japan for use in patients with refractory nephrotic syndrome. To meet the conditions of approval, an all-case post-marketing surveillance study was conducted to confirm the real-world safety and efficacy of rituximab in patients of all ages with refractory nephrotic syndrome. Methods All patients scheduled to receive rituximab treatment for refractory nephrotic syndrome were eligible to register (registration: August 29, 2014 through April 15, 2016); the planned observation period was 2 years from the initiation of rituximab treatment (intravenous infusion, 375 mg/m2 once weekly for four doses). The study was conducted at 227 hospitals throughout Japan. Adverse drug reactions (ADRs) were collected for safety outcomes. The efficacy outcomes were relapse-free period and the degree of growth in pediatric (< 15 years) patients. Results In total, 997 (447 pediatric) patients were registered; 981 (445) were included in the safety analysis set; 852 (402) completed the 2-year observation period; and 810 (429) were included in the efficacy analysis set. Refractory nephrotic syndrome had developed in childhood for 85.0% of patients, and 54.6% were aged ≥15 years. ADRs were observed in 527 (53.7%) patients, treatment-related infection/infestation in 235 (24.0%) patients, and infusion reactions in 313 (31.9%) patients. The relapse-free period was 580 days (95% confidence interval, 511–664). There was a significant change in height standard deviation score (pediatric patients; mean change, 0.093; standard deviation, 0.637; P = 0.009). Conclusion The safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome were confirmed in the real-world setting. Clinical trial registration UMIN000014997.

Safety and efficacy of therapeutic early onset granulocyte transfusions in pediatric patients with neutropenia and severe infections

Transfusion ◽  
2006 ◽  
Vol 46 (11) ◽  
pp. 1909-1914 ◽  
Author(s):  
Ulrich J.H. Sachs ◽  
Alfred Reiter ◽  
Tobias Walter ◽  
Gregor Bein ◽  
Wilhelm Woessmann
Keyword(s):  
Early Onset ◽  
Pediatric Patients ◽  
Safety And Efficacy ◽  
Severe Infections

scholarly journals P6195Experience with safety and efficacy of levosimendan in pediatric patients

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
C Mulatier ◽  
C Galoin Bertail ◽  
T Perouse De Montclos ◽  
M Bakloul ◽  
C Durrousset ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Safety And Efficacy

Sa2067 Safety and Efficacy of Endoscopic Retrograde Cholangiopancreatography in Pediatric Patients: A 7-Year Experience

2016 ◽  
Vol 83 (5) ◽  
pp. AB304-AB305 ◽  
Author(s):  
Parit Mekaroonkamol ◽  
Jose Nieto ◽  
Saurabh Chawla ◽  
Alvin J. Freeman ◽  
Zaid Alnoah ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Pediatric Patients ◽  
Endoscopic Retrograde ◽  
Safety And Efficacy
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