Literature DB >> 29298113

ClinicalTrials.gov for Facilitating Rapid Understanding of Potential Harms of New Drugs: The Case of Checkpoint Inhibitors.

Annie Yang1, Shrujal Baxi1, Deborah Korenstein1.   

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Year:  2018        PMID： 29298113      PMCID： PMC5812307          DOI： 10.1200/JOP.2017.025114

Source DB:  PubMed          Journal:  J Oncol Pract        ISSN： 1554-7477            Impact factor:   3.840


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  43 in total

1.  Timing of new black box warnings and withdrawals for prescription medications.

Authors:  Karen E Lasser; Paul D Allen; Steffie J Woolhandler; David U Himmelstein; Sidney M Wolfe; David H Bor
Journal:  JAMA       Date:  2002-05-01       Impact factor: 56.272

2.  Clinical Trials Registration and Results Information Submission. Final rule.

Authors: 
Journal:  Fed Regist       Date:  2016-09-21

3.  Trial Reporting in ClinicalTrials.gov - The Final Rule.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Sarah Carr
Journal:  N Engl J Med       Date:  2016-09-16       Impact factor: 91.245

4.  Nivolumab and ipilimumab versus ipilimumab in untreated melanoma.

Authors:  Michael A Postow; Jason Chesney; Anna C Pavlick; Caroline Robert; Kenneth Grossmann; David McDermott; Gerald P Linette; Nicolas Meyer; Jeffrey K Giguere; Sanjiv S Agarwala; Montaser Shaheen; Marc S Ernstoff; David Minor; April K Salama; Matthew Taylor; Patrick A Ott; Linda M Rollin; Christine Horak; Paul Gagnier; Jedd D Wolchok; F Stephen Hodi
Journal:  N Engl J Med       Date:  2015-04-20       Impact factor: 91.245

5.  Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer.

Authors:  Hossein Borghaei; Luis Paz-Ares; Leora Horn; David R Spigel; Martin Steins; Neal E Ready; Laura Q Chow; Everett E Vokes; Enriqueta Felip; Esther Holgado; Fabrice Barlesi; Martin Kohlhäufl; Oscar Arrieta; Marco Angelo Burgio; Jérôme Fayette; Hervé Lena; Elena Poddubskaya; David E Gerber; Scott N Gettinger; Charles M Rudin; Naiyer Rizvi; Lucio Crinò; George R Blumenschein; Scott J Antonia; Cécile Dorange; Christopher T Harbison; Friedrich Graf Finckenstein; Julie R Brahmer
Journal:  N Engl J Med       Date:  2015-09-27       Impact factor: 91.245

6.  Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial.

Authors:  Jeffrey S Weber; Geoff Gibney; Ryan J Sullivan; Jeffrey A Sosman; Craig L Slingluff; Donald P Lawrence; Theodore F Logan; Lynn M Schuchter; Suresh Nair; Leslie Fecher; Elizabeth I Buchbinder; Elmer Berghorn; Mary Ruisi; George Kong; Joel Jiang; Christine Horak; F Stephen Hodi
Journal:  Lancet Oncol       Date:  2016-06-04       Impact factor: 41.316

7.  ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

Authors:  Lisa M Schwartz; Steven Woloshin; Eugene Zheng; Tony Tse; Deborah A Zarin
Journal:  Ann Intern Med       Date:  2016-06-14       Impact factor: 25.391

Review 8.  Underreporting of hemorrhagic and thrombotic complications of pharmaceuticals to the U.S. Food and Drug Administration: empirical findings for warfarin, clopidogrel, ticlopidine, and thalidomide from the Southern Network on Adverse Reactions (SONAR).

Authors:  Thomas J Moore; Charles L Bennett
Journal:  Semin Thromb Hemost       Date:  2012-10-21       Impact factor: 4.180

9.  Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter phase 2 trial.

Authors:  M Reck; I Bondarenko; A Luft; P Serwatowski; F Barlesi; R Chacko; M Sebastian; H Lu; J-M Cuillerot; T J Lynch
Journal:  Ann Oncol       Date:  2012-08-02       Impact factor: 32.976

10.  Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20).

Authors:  D McDermott; J Haanen; T-T Chen; P Lorigan; S O'Day
Journal:  Ann Oncol       Date:  2013-08-13       Impact factor: 32.976
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  5 in total

1.  Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement.

Authors:  Apostolia M Tsimberidou; Laura A Levit; Richard L Schilsky; Steven D Averbuch; Daniel Chen; John M Kirkwood; Lisa M McShane; Elad Sharon; Kathryn F Mileham; Michael A Postow
Journal:  J Clin Oncol       Date:  2018-10-19       Impact factor: 44.544

2.  Clinical trial registration during COVID-19 and beyond in the African context: what have we learned?

Authors:  Lindi Mathebula; Sinazo Runeyi; Charles Wiysonge; Duduzile Ndwandwe
Journal:  Trials       Date:  2022-06-06       Impact factor: 2.728

3.  The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors.

Authors:  Zahra Karimian; Sandra Mavoungou; Joe-Elie Salem; Florence Tubach; Agnès Dechartres
Journal:  BMC Cancer       Date:  2020-11-23       Impact factor: 4.430

4.  Trial Reporting in Immuno-Oncology (TRIO): an American society of clinical oncology-society for immunotherapy of cancer statement.

Authors:  Apostolia M Tsimberidou; Laura A Levit; Richard L Schilsky; Steven D Averbuch; Daniel Chen; John M Kirkwood; Lisa M McShane; Elad Sharon; Kathryn F Mileham; Michael A Postow
Journal:  J Immunother Cancer       Date:  2018-10-19       Impact factor: 13.751

5.  Quality of life in long-term survivors of advanced melanoma treated with checkpoint inhibitors.

Authors:  Maha Mamoor; Michael A Postow; Jessica A Lavery; Shrujal S Baxi; Niloufer Khan; Jun J Mao; Lauren J Rogak; Robert Sidlow; Bridgette Thom; Jedd A Wolchok; Deborah Korenstein
Journal:  J Immunother Cancer       Date:  2020-03       Impact factor: 13.751
  5 in total

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