scholarly journals Sirolimus Adverse Event Profile in a Non-Clinical Trial Cohort of Heart Transplantation Patients

2021 ◽  
Vol 26 ◽  
Author(s):  
Karim Sallam ◽  
Geetha P. Bhumireddy ◽  
Vishnu D. Evuri ◽  
Joshua P. Abella ◽  
Francois Haddad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Heart Transplantation ◽  
Adverse Event Profile

scholarly journals Brivaracetam: a newly approved medication for epilepsy

2019 ◽  
Vol 14 (3) ◽  
pp. FNL23
Author(s):  
Joel M Oster
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Dose Finding ◽  
Adjunctive Treatment ◽  
Adverse Event Profile ◽  
Focal Seizures ◽  
The Usa ◽  
Clinical Trial Program ◽  
The Eu

Brivaracetam (BRV) in both the USA and EU was developed as a novel molecule for the adjunctive treatment of partial-onset (focal) seizures in patients ≥16 years of age and as of September 2017 was approved for use as monotherapy in the USA uniquely as an antiseizure medication that may be prescribed without a dose finding uptitration. This article reviews BRV's pharmacology, efficacy, safety and adverse event profiles, along with the relevant and noted regulatory hurdles in the USA and the EU. Available postmarketing data will also be summarized. Approximately 3000 patients were studied over about 9 years in the clinical trial program illustrating that BRV has efficacy at 50–200 mg/day with an acceptable adverse event profile.

scholarly journals Evaluation of the adverse event profile and pharmacodynamics of toceranib phosphate administered to dogs with solid tumors at doses below the maximum tolerated dose

2013 ◽  
Vol 9 (1) ◽  
pp. 190 ◽  
Author(s):  
Luis Bernabe ◽  
Roberta Portela ◽  
Sandra Nguyen ◽  
William C Kisseberth ◽  
Michael Pennell ◽  
...  
Keyword(s):  
Adverse Event ◽  
Solid Tumors ◽  
Maximum Tolerated Dose ◽  
Adverse Event Profile

Adverse Event Profile of Eluxadoline Over Time in Patients With Irritable Bowel Syndrome With Diarrhea

2015 ◽  
Vol 110 ◽  
pp. S748-S749 ◽  
Author(s):  
Brooks D. Cash ◽  
Philip S. Schoenfeld ◽  
Brian E. Lacy ◽  
Leonard S. Dove ◽  
Paul S. Covington
Keyword(s):  
Adverse Event ◽  
Irritable Bowel Syndrome ◽  
Adverse Event Profile ◽  
Irritable Bowel ◽  
Over Time

scholarly journals Value of clinical trial narrative data to estimate the costs of adverse event management: a feasibility study

2019 ◽  
Vol 23 (3) ◽  
pp. 213-220
Author(s):  
Deirdre Mladsi ◽  
Lisa M. Hess ◽  
Christine L. Barnett ◽  
Annete Njue ◽  
Yu-Jing Huang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Feasibility Study ◽  
Event Management ◽  
Adverse Event Management

Long-term adverse event profile from four completed trials of oral eliglustat in adults with Gaucher disease type 1

2018 ◽  
Vol 123 (2) ◽  
pp. S116 ◽  
Author(s):  
M. Judith Peterschmitt ◽  
Audrey Hou ◽  
Lisa H. Underhill ◽  
Yaoshi Wu ◽  
Sebastiaan J.M. Gaemers
Keyword(s):  
Adverse Event ◽  
Gaucher Disease ◽  
Disease Type ◽  
Adverse Event Profile ◽  
Gaucher Disease Type 1

scholarly journals The adverse event profile of brivaracetam: A meta-analysis of randomized controlled trials

Seizure ◽  
2017 ◽  
Vol 45 ◽  
pp. 7-16 ◽  
Author(s):  
Li-na Zhu ◽  
Deng Chen ◽  
Tao Chen ◽  
Da Xu ◽  
Si-han Chen ◽  
...  
Keyword(s):  
Adverse Event ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Adverse Event Profile ◽  
Randomized Controlled
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