Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea

2021 ◽  
Vol Volume 15 ◽  
pp. 3623-3636 ◽  
Author(s):  
Min Seok Kim ◽  
Jasmine Choi ◽  
Hyeong Du Lee ◽  
Se Joon Woo
Keyword(s):  
Macular Edema ◽  
Real World ◽  
Post Hoc Analysis ◽  
Dexamethasone Intravitreal Implant ◽  
Vein Occlusion ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Intravitreal Implant ◽  
Post Marketing ◽  
Post Hoc

scholarly journals Real-world safety and effectiveness of nivolumab for recurrent or metastatic head and neck cancer in Japan: a post-marketing surveillance

2021 ◽  
Author(s):  
Makoto Tahara ◽  
Naomi Kiyota ◽  
Ken-ichi Nibu ◽  
Ayumi Akamatsu ◽  
Tomohiro Hoshino ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Interstitial Lung Disease ◽  
Head And Neck ◽  
Neck Cancer ◽  
Real World ◽  
Special Interest ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Safety Signals

Abstract Background On the basis of phase III CheckMate 141 results, nivolumab was approved for recurrent or metastatic head and neck cancer after undergoing platinum-containing chemotherapy in Japan. This post-marketing surveillance aimed to evaluate the safety and effectiveness of nivolumab for head and neck cancer in the real-world setting. Methods All patients with head and neck cancer who planned to receive nivolumab were centrally registered. This study monitored 607 patients for 6 months to assess nivolumab’s safety, especially treatment-related adverse events (TRAEs) of special interest, and effectiveness. Results TRAEs occurred in 36.1% patients, with no new safety signals. The most common TRAEs with grade ≥ 3 were interstitial lung disease (1.2%), diarrhea (0.8%), and hepatic function abnormal (0.7%). Meanwhile, thyroid dysfunction (10.2%), hepatic dysfunction (5.3%), and interstitial lung disease (4.1%) were the most common TRAE categories of special interest. Although the median time to the onset of each TRAE category of special interest was mostly 1–2 months, most of them occurred throughout the observation period; nonetheless, the majority of patients recovered or remitted. The 6-month survival rate was 55.9%. Conclusion Japanese patients with head and neck cancer treated with nivolumab in the real-world setting manifested no new safety signals. Clinical Trial Registration clinicaltrials.jp: JapicCTI-184071.

Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion

Ophthalmology ◽  
2010 ◽  
Vol 117 (6) ◽  
pp. 1134-1146.e3 ◽  
Author(s):  
Julia A. Haller ◽  
Francesco Bandello ◽  
Rubens Belfort ◽  
Mark S. Blumenkranz ◽  
Mark Gillies ◽  
...  
Keyword(s):  
Macular Edema ◽  
Retinal Vein Occlusion ◽  
Controlled Trial ◽  
Dexamethasone Intravitreal Implant ◽  
Vein Occlusion ◽  
Intravitreal Implant
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