a post|hoc analysis of phase 3 trials and long|term extension

a post-hoc analysis of phase 3 trials and long-term extension

Tofacitinib efficacy exceeded placebo in both sexes and was comparable between sexes. Consistent with previous studies of PsA treatments, females were less ...

a post-hoc analysis of phase 3 trials and long-term extension - Pfizer

Plain language summary for the manuscript: Sex differences in the efficacy, safety, and persistence of patients with psoriatic arthritis ...

analyses of a phase III study and long-term extension - PubMed

Avatrombopag is an oral thrombopoietin receptor agonist approved for chronic immune thrombocytopenia (ITP). This is a post hoc analysis of ...

Sex Differences in the Efficacy and Safety of Tofacitinib in ...

... A Post Hoc Analysis of Phase 3 and Long-Term Extension Trials. Niall Jones1, Vibeke Strand2, Hendrik Schulze-Koops3, Eduardo Mysler4 ...

Post hoc analysis of a phase 3 study for treatment of uncontrolled ...

Sasamoto, et al. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: a long-term, open-label extension ...

New post-hoc analysis pooling two clinical trials demonstrates ...

... Long-term Extension (Abstract OP110). Presented at the UEGW Virtual 2020 Congress October 11—13. 7 EU Clinical Trials Register. A Phase 2/3 ...

Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety ...

Post hoc analyses of data from CD patients treated with vedolizumab in the GEMINI 2, GEMINI 3, and GEMINI LTS trials [N = 1253] evaluated CD- ...

A Randomized, Placebo‐Controlled Phase III Extension Trial of the ...

To explore long-term safety and tolerability of anifrolumab 300 mg compared with placebo in patients with systemic lupus erythematosus (SLE)

POS0652 SEX DIFFERENCES IN THE EFFICACY AND SAFETY OF ...

... A POST HOC ANALYSIS OF PHASE 3 AND LONG-TERM EXTENSION TRIALS. Free. Loading. H. N. Jones1,; V. Strand2,; H. Schulze-Koops3,; E. Mysler4,; C. Kinch5,; D. C. ...

... analysis from the phase 3 (KEEPsAKE 1 and KEEPsAKE 2) studies ... a post-hoc analysis of phase 3 trials and long-term extension. RMD ...

Articles Safety and efficacy of tofacitinib up to 48 months in patients ...

Here we report the final analysis of Oral Psoriatic Arthritis Trial (OPAL) Balance, a 36-month long-term extension study, with a 12-month methotrexate ...

Post hoc analysis of patients with rheumatoid arthritis under clinical ...

This post hoc analysis of data from two Phase 3 studies (RAJ3 and RAJ4) ... a post hoc analysis of phase 3 and long-term extension trials . Ann Rheum ...

Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ...

Key Points. Extended ibrutinib treatment showed sustained PFS in previously treated patients with CLL, including those with high-risk ...

Long-Term Follow-Up Data from Two Phase 3 Studies of CAMZYOS ...

... cardiomyopathy (HCM). Results from the 56-week analysis of the VALOR-HCM long-term extension (LTE) study were presented as a late-breaking oral.

A Framework for Extension Studies Using Real-World Data to ...

This prospective follow-up aimed to assess any long-term effects—6–8 years after randomization—of the 14-month treatments in the MTA study [3].

Long-term Efficacy and Safety From an Open-Label Extension of ...

The double-blind treatment period included a 6-week titration phase and a 12-week maintenance phase. Patients who completed the double-blind study and still met ...

Post hoc analysis of clinical trial data and pharmacokinetic data to ...

Data from extension phases were not assessed in this post hoc analysis. ... analysis of six placebo-controlled trials with long-term extensions.

E 9 Statistical Principles for Clinical Trials Step 5

example, in long term trials, where growing medical knowledge either from outside the trial or from interim analyses may suggest a change of entry criteria.

Long-term follow-up from the ORATORIO trial of ocrelizumab for ...

... a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial. Prof Jerry S Wolinsky, MD.

Assessment of Long-term Follow-up of Randomized Trial ...

These are categorized in Table 3. Seventy-four analyses (47.7%) identified statistically significant benefits in the trial extension phase.