scholarly journals Safety of gadoxetate disodium: Results from the clinical phase II–III development program and postmarketing surveillance

2015 ◽  
Vol 42 (3) ◽  
pp. 634-643 ◽  
Author(s):  
Jan S. Endrikat ◽  
Susan Dohanish ◽  
Thomas Balzer ◽  
Josy A.M. Breuer
Keyword(s):  
Phase Ii ◽  
Development Program ◽  
Postmarketing Surveillance ◽  
Gadoxetate Disodium ◽  
Clinical Phase

scholarly journals Safety profile of gadoxetate disodium in elderly patients (≥65 years)

2017 ◽  
Vol 59 (1) ◽  
pp. 81-88 ◽  
Author(s):  
Jan Endrikat ◽  
Carsten Schwenke ◽  
Kai Vogtlaender ◽  
Susan Dohannish ◽  
Josy Breuer
Keyword(s):  
Elderly Patients ◽  
Phase Ii ◽  
Safety Profile ◽  
Clinical Studies ◽  
Safety Data ◽  
Gadoxetate Disodium ◽  
Total N ◽  
Clinical Phase ◽  
Pharmacovigilance Database ◽  
Post Marketing

Background Safety data on routine clinical use of gadoxetate disodium in elderly patients is not reported yet. Purpose To assess the safety of liver specific gadoxetate disodium in contrast enhanced magnetic resonance imaging in elderly patients (≥65 years) in comparison to adults (18–64 years). Material and Methods Safety data on gadoxetate disodium were analyzed from 12 clinical phase II–III studies and from our pharmacovigilance database. A comparison between elderly (≥65 years) versus adults (18–64 years) was performed with respect to the frequency of drug-related adverse events (AEs) in clinical phase II–III studies and adverse drug reactions (ADRs) in the pharmacovigilance database. Results In clinical studies, 1989 patients were enrolled: 675 elderly and 1314 adults. Twenty-three elderly patients (3.4%) suffered at least one drug-related AE in contrast to 58 patients (4.4%) in the group of adults (odds ratio = 0.76; 95% confidence interval = 0.45–1.27). Since marketing authorization in 2004, more than 3.5 million patients have been exposed to gadoxetate disodium worldwide: 1.7 million (48.6%) in elderly and 1.8 million (51.4%) in adults. The number of patients with post-marketing ADRs (total n = 793) was 354 (0.021%) in the elderly group and 439 (0.024%) in the adult group. Thus, there were significantly fewer patients with ADRs reported in the group of elderly versus adults ( P = 0.028). Hypersensitivity/immune system disorders, gastrointestinal disorders, and respiratory disorders were the most frequent ADRs in both groups, elderly and adults. Conclusion The incidence of drug-related AEs in clinical studies was similar and that of patients with ADRs in the post-marketing setting was lower in elderly (≥65 years) compared with younger adults aged 18–64 years. Overall, gadoxetate disodium shows a favorable safety profile in both age groups.

scholarly journals A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease

Ophthalmology ◽  
2019 ◽  
Vol 126 (6) ◽  
pp. 792-800 ◽  
Author(s):  
David L. Wirta ◽  
Gail L. Torkildsen ◽  
Helen R. Moreira ◽  
John D. Lonsdale ◽  
Joseph B. Ciolino ◽  
...  
Keyword(s):  
Phase Ii ◽  
Dry Eye ◽  
Phase Ii Study ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Clinical Phase

A Clinical Phase II Study of a Non-Anthracycline Sequential Combination of Cisplatin-Vinorelbine Followed by Docetaxel as First-Line Treatment in Metastatic Breast Cancer

Oncology ◽  
2006 ◽  
Vol 70 (5) ◽  
pp. 330-338 ◽  
Author(s):  
Ali I. Shamseddine ◽  
Zaher K. Otrock ◽  
Mohamad J. Khalifeh ◽  
Hanan R. Yassine ◽  
Maya Charafeddine ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
Clinical Phase ◽  
Sequential Combination ◽  
First Line Treatment

4?-Epi-doxorubicin ? A clinical phase-II trial in solid tumors

1984 ◽  
Vol 107 (1) ◽  
pp. 38-41 ◽  
Author(s):  
J. Sch�tte ◽  
N. Niederle ◽  
B. Grunenberg ◽  
W. Krischke ◽  
S. Seeber ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Clinical Phase

scholarly journals Effects of preoperative oral carbohydrate intake on catabolism, nutrition and adipocytokines during minor surgery: A randomized, prospective, controlled clinical phase II trial

PLoS ONE ◽  
2019 ◽  
Vol 14 (5) ◽  
pp. e0216525 ◽  
Author(s):  
Yoshinari Morimoto ◽  
Tomoko Kinugawa ◽  
Megumi Hayashi ◽  
Takatoshi Iida ◽  
Tatsuo Yamamoto
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Carbohydrate Intake ◽  
Clinical Phase ◽  
Minor Surgery

scholarly journals Clinical phase II and III studies of an AS03‐adjuvanted H5N1 influenza vaccine produced in an EB66 ® cell culture platform

2020 ◽  
Vol 14 (5) ◽  
pp. 551-563
Author(s):  
Masafumi Endo ◽  
Mitsuyoshi Tanishima ◽  
Kayo Ibaragi ◽  
Kenshi Hayashida ◽  
Tadashi Fukuda ◽  
...  
Keyword(s):  
Cell Culture ◽  
Influenza Vaccine ◽  
Phase Ii ◽  
Clinical Phase ◽  
H5n1 Influenza ◽  
Phase Ii And Iii
Sign in / Sign up

Export Citation Format

Share Document