scholarly journals Efficacy and Safety of Risedronate in Osteoporosis Subjects with Comorbid Diabetes, Hypertension, and/or Dyslipidemia: A Post Hoc Analysis of Phase III Trials Conducted in Japan

2015 ◽  
Vol 98 (2) ◽  
pp. 114-122 ◽  
Author(s):  
Daisuke Inoue ◽  
Ryoichi Muraoka ◽  
Ryo Okazaki ◽  
Yoshiki Nishizawa ◽  
Toshitsugu Sugimoto
Keyword(s):  
Phase Iii ◽  
Efficacy And Safety ◽  
Post Hoc Analysis ◽  
Phase Iii Trials ◽  
Post Hoc

Post-hoc analysis from phase III trials of human papillomavirus vaccines: considerations on impact on non-vaccine types

2019 ◽  
Vol 18 (3) ◽  
pp. 309-322 ◽  
Author(s):  
Martin Ryser ◽  
Valérie Berlaimont ◽  
Naveen Karkada ◽  
Attila Mihalyi ◽  
Rino Rappuoli ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Phase Iii ◽  
Papillomavirus Vaccines ◽  
Human Papillomavirus Vaccines ◽  
Post Hoc Analysis ◽  
Phase Iii Trials ◽  
Post Hoc

scholarly journals Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis

2020 ◽  
Author(s):  
Cesar Margarit Ferri ◽  
Silvia Natoli ◽  
Paz Sanz-Ayan ◽  
Alberto Magni ◽  
Carlos Guerrero ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Phase Iii ◽  
Prolonged Release ◽  
Post Hoc Analysis ◽  
Three Phase ◽  
Sf 36 ◽  
Phase Iii Trials ◽  
Post Hoc

Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.

Lenalidomide (LEN)-melphalan-prednisone induction followed by LEN maintenance (MPR-R) in newly diagnosed multiple myeloma (NDMM) elderly patients (Pts) with moderate renal impairment (RI): MM-015 trial post-hoc analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8544-8544
Author(s):  
John V. Catalano ◽  
Antonio Palumbo ◽  
Katja C. Weisel ◽  
Meletios A. Dimopoulos ◽  
Michel Delforge ◽  
...  
Keyword(s):  
Phase Iii ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Pivotal Phase ◽  
Phase Iii Trial ◽  
Post Hoc Analysis ◽  
Negative Prognostic Factor ◽  
Starting Dose ◽  
Post Hoc ◽  
Clinical Trial Information

8544 Background: The MM-015 pivotal phase III trial showed significant PFS benefit for MPR-R (31 mos) vs. MPR (14 mos) or MP (13 mos; both p < 0.001) followed by placebo in NDMM pts aged ≥ 65 years. As NDMM pts with RI have poor prognosis, this retrospective analysis studied the efficacy and safety of MPR-R in pts with creatinine clearance (CrCl) < 60 mL/min. Methods: LEN starting dose for induction/maintenance was 10 mg/day (D1–21 of a 28-day cycle). Dose adjustments were not recommended for pts with RI. CrCl was calculated using the Cockcroft-Gault equation. Pts with severe RI (serum Cr > 2.5 mg/dL [221 μmol/L]) were excluded from the trial. Results: Pts with CrCl < 60 mL/min (median 47, interquartile range [IQR] 38–55) were included in this analysis: 51% MPR-R, 45% MPR, and 49% MP. Median PFS was significantly higher with MPR-R (26 mos [95% CI 14–48]) vs. MPR (13 mos [95% CI 12–15]) or MP (14 mos [95% CI 12–16]; both p < 0.001). In a Cox proportional model of PFS, CrCl < 60 mL/min was not identified as a negative prognostic factor (p = 0.69). The most common Gr 4 adverse events (AEs) were hematologic and occurred predominantly during induction and are shown in the Table for pts with or without moderate RI. The number of deaths on study was similar: 10% (MPR-R), 7% (MPR), and 8% (MP); deaths associated with RI or disease progression were reported in ≤ 1% of pts with RI across the arms. Conclusions: The benefit of continuous LEN treatment with MPR-R is not compromised in NDMM pts with moderate RI, consistent with the overall trial results. CrCl and AEs should be monitored closely in this population. Clinical trial information: NCT00405756. [Table: see text]

scholarly journals Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001621
Author(s):  
Daniel Aletaha ◽  
René Westhovens ◽  
Cecile Gaujoux-Viala ◽  
Giovanni Adami ◽  
Alan Matsumoto ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Prognostic Factors ◽  
Structural Damage ◽  
High Sensitivity ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
American College Of Rheumatology ◽  
Post Hoc

ObjectiveThis analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).MethodsThis was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population.ResultsOf 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed.ConclusionFIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.

scholarly journals A multivariable prediction model of a major treatment response for focal-onset seizures: a post-hoc analysis of Phase III trials of perampanel

2021 ◽  
pp. 106649
Author(s):  
Gregory L. Krauss ◽  
Elinor Ben-Menachem ◽  
Robert T. Wechsler ◽  
Anna Patten ◽  
Betsy Williams ◽  
...  
Keyword(s):  
Prediction Model ◽  
Treatment Response ◽  
Phase Iii ◽  
Post Hoc Analysis ◽  
Phase Iii Trials ◽  
Major Treatment ◽  
Post Hoc

scholarly journals Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies

2021 ◽  
Author(s):  
Tobias Welte ◽  
Thomas WL Scheeren ◽  
J Scott Overcash ◽  
Mikael Saulay ◽  
Marc Engelhardt ◽  
...  
Keyword(s):  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Skin Structure ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Hospital Acquired ◽  
Phase Iii Studies

Aim: To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. Materials & methods: We conducted a post hoc analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Results: Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16.3% [95% CI:1.8–30.8]). The safety profile was similar between treatment groups in all studies. Conclusion: This analysis further supports the efficacy and safety of ceftobiprole in older patients with acute bacterial skin and skin structure infections or pneumonia. Clinicaltrials.gov trial identifiers: NCT03137173 , NCT00326287 , NCT00210964 , NCT00229008

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