Spontaneous adverse event reports in the USA

2018 ◽  
Vol 1702 (1) ◽  
pp. 11-11
Keyword(s):  
Adverse Event ◽  
The Usa ◽  
Spontaneous Adverse Event

Understanding the adverse event experience in the S-TRAC adjuvant trial of sunitinib for high-risk renal cell carcinoma

2020 ◽  
Vol 16 (4) ◽  
pp. 39-47
Author(s):  
Sarah Yenser Wood ◽  
Joanne C Ryan ◽  
Andrew G Clair ◽  
Daniel J George
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Event ◽  
High Risk ◽  
Cell Carcinoma ◽  
Adjuvant Treatment ◽  
Renal Cell ◽  
Disease Recurrence ◽  
Event Management ◽  
The Usa ◽  
Metastatic Rcc

Until recently, the sole treatment for patients with nonmetastatic renal cell carcinoma (RCC) was nephrectomy followed by observation. As metastatic RCC (mRCC) remains largely incurable (5-year survival rate ∼12%), adjuvant treatment, with potential to prevent/delay disease recurrence, is needed. In November 2017, sunitinib was approved in the USA as the first adjuvant therapy for patients at high risk for recurrent RCC postnephrectomy based on results from the S-TRAC trial. Patients eligible for adjuvant treatment have no evidence of disease and may be less willing to tolerate side effects. Therefore, proactive adverse event management is critical for keeping patients on adjuvant treatment and requires understanding the subtle differences in the adverse event profile of sunitinib in the adjuvant versus metastatic RCC setting.

scholarly journals Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

2017 ◽  
Vol 13 (02) ◽  
pp. 223-234 ◽  
Author(s):  
Carmen K. Wong ◽  
Nathaniel S. Marshall ◽  
Ronald R. Grunstein ◽  
Samuel S. Ho ◽  
Romano A. Fois ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
The United States ◽  
Spontaneous Adverse Event

Spontaneous adverse event reports associated with zolpidem

2016 ◽  
Vol 12 (5) ◽  
pp. e24
Author(s):  
Carmen K. Wong ◽  
Nathaniel S. Marshall ◽  
Ronald R. Grunstein ◽  
David E. Hibbs ◽  
Romano A. Fois ◽  
...  
Keyword(s):  
Adverse Event ◽  
Spontaneous Adverse Event

Evaluation of Spontaneous Adverse Event Reports by Primary Reporter—A 15-Year Review (1983 to 1997)

1999 ◽  
Vol 33 (4) ◽  
pp. 1117-1124 ◽  
Author(s):  
Kenneth Hornbuckle ◽  
Hsiao-Hui Wu ◽  
Man C. Fung
Keyword(s):  
Adverse Event ◽  
Spontaneous Adverse Event

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan

2019 ◽  
Vol 105 (6) ◽  
pp. 1471-1476 ◽  
Author(s):  
Akina Takami ◽  
Kaori Hirata ◽  
Chieko Ishiguro ◽  
Hideki Hanaoka ◽  
Yoshiaki Uyama
Keyword(s):  
Adverse Event ◽  
Generic Drugs ◽  
Lower Proportion ◽  
Branded Drugs ◽  
Spontaneous Adverse Event
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