Safety Evaluation Across Phase 2/3 Studies of Tapentadol for Drug-related Hepatic Disorders: Standardized Medical Dictionary of Regulatory Activities (MedDRA) Query Results: 408Pei, HuilingOkamoto, AkikoOh, CharlesLaschewski, FrankFlügel, Maren
Ethics approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Institutional Review Board of the Netherlands Cancer Institute; M17QOL) and with the 1964 Helsinki declaration and its late...
These percentages are similar to those in the phase 3 studies that also assessed immune responses across additional test strains, with 75% to 100% of adolescents and 72% to 99% of young adults with hSBA titers ≥ LLOQ at 1 month after dose 3 for the additional test strains, ...
The TEAM study was a prospective, multicenter, randomized, double-blind, sham-controlled, Phase 3 trial for 2-h, continuous, e-TNS treatment of a single moderate or severe migraine attack at home. A total of 538 adults meeting the International Classification of Headache Disorders 3rd edition ...
The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries -- the largest program of any anticoagulant performed in Cancer-...
Although pharmacokinetic data have indicated that darolutamide has the potential to interact with rosuvastatin, used to assess DDI in these studies, this finding did not seem to translate into increased AEs due to statin use in the ARAMIS trial. Clinicaltrials.gov identifier: NCT02200614. 展开 ...
This guidance provides recommendations to sponsors of investigational new drug applications (INDs) on the chemistry, manufacturing, and controls (CMC) information that would be submitted for phase 2 and phase 3 studies conducted under INDs.
DRUG INTERACTIONS Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. CYP3A...
This is because even a small variance (e.g., 5%) of the actual control success rate away from the historical success rate rockets the false positive rate in single-arm studies by 2- to 3-fold (34). Thus, the drug may falsely appear in a phase II study to demonstrate the level of ...
26,27 Herein, we describe 2 identical phase 3 studies evaluating the efficacy and safety of topical clascoterone cream, 1%, vs vehicle cream applied twice daily for 12 weeks in patients with facial acne vulgaris. Methods Trial Design The CB-03-01/25 and CB-03-01/26 trials were identical...