Works matching AU Carroll, Kevin J.

Results: 21

Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer.

Published in:

2016

By:

Dalgleish, Angus G;
Stebbing, Justin;
Adamson, Douglas J A;
Arif, Seema Safia;
Bidoli, Paolo;
Chang, David;
Cheeseman, Sue;
Diaz-Beveridge, Robert;
Fernandez-Martos, Carlos;
Glynne-Jones, Rob;
Granetto, Cristina;
Massuti, Bartomeu;
McAdam, Karen;
McDermott, Raymond;
Martín, Andrés J Muñoz;
Papamichael, Demetris;
Pazo-Cid, Roberto;
Vieitez, Jose M;
Zaniboni, Alberto;
Carroll, Kevin J

Publication type:

journal article

Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer.

Published in:

2016

By:

Dalgleish, Angus G;
Stebbing, Justin;
Adamson, Douglas JA;
Arif, Seema Safia;
Bidoli, Paolo;
Chang, David;
Cheeseman, Sue;
Diaz-Beveridge, Robert;
Fernandez-Martos, Carlos;
Glynne-Jones, Rob;
Granetto, Cristina;
Massuti, Bartomeu;
McAdam, Karen;
McDermott, Raymond;
Martín, Andrés J Muñoz;
Papamichael, Demetris;
Pazo-Cid, Roberto;
Vieitez, Jose M;
Zaniboni, Alberto;
Carroll, Kevin J

Publication type:

journal article

Subsequent urinary stone events are predicted by the magnitude of urinary oxalate excretion in enteric hyperoxaluria.

Published in:

Nephrology Dialysis Transplantation, 2021, v. 36, n. 12, p. 2208, doi. 10.1093/ndt/gfaa281

By:

D'Costa, Matthew R;
Kausz, Annamaria T;
Carroll, Kevin J;
Ingimarsson, Jóhann P;
Enders, Felicity T;
Mara, Kristin C;
Mehta, Ramila A;
Lieske, John C

Publication type:

Article

Camlipixant in Refractory Chronic Cough: A Phase 2a, Randomized Controlled Trial (RELIEF).

Published in:

American Journal of Respiratory & Critical Care Medicine, 2025, v. 211, n. 6, p. 1072, doi. 10.1164/rccm.202501-0093RL

By:

Smith, Jaclyn A.;
Morice, Alyn H.;
Birring, Surinder S.;
Parker, Sean M.;
Marsden, Paul A.;
Holcomb, John R.;
Sher, Mandel;
Prenner, Bruce M.;
Steven, Gary;
Carroll, Kevin J.;
Lanouette, Sylvain;
Garceau, Denis;
Harvey, Laurent;
Bonuccelli, Catherine M.

Publication type:

Article

Camlipixant in Refractory Chronic Cough: A Phase 2b, Randomized, Placebo-controlled Trial (SOOTHE).

Published in:

American Journal of Respiratory & Critical Care Medicine, 2025, v. 211, n. 6, p. 1038, doi. 10.1164/rccm.202409-1752OC

By:

Smith, Jaclyn A.;
Birring, Surinder S.;
Blaiss, Michael S.;
McGarvey, Lorcan;
Morice, Alyn H.;
Sher, Mandel;
Carroll, Kevin J.;
Garin, Margaret;
Lanouette, Sylvain;
Shaw, Joan;
Yang, Ronghua;
Bonuccelli, Catherine M.

Publication type:

Article

Batch Selection via In Vitro/In Vivo Correlation in Pharmacokinetic Bioequivalence Testing.

Published in:

AAPS PharmSciTech, 2021, v. 22, n. 7, p. 1, doi. 10.1208/s12249-021-02064-0

By:

Burmeister Getz, Elise;
Carroll, Kevin J.;
Mielke, Johanna;
Jones, Byron;
Benet, Leslie Z.

Publication type:

Article

Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability.

Published in:

AAPS PharmSciTech, 2021, v. 22, n. 7, p. 1, doi. 10.1208/s12249-021-02063-1

By:

Burmeister Getz, Elise;
Carroll, Kevin J.;
Christopher, J. David;
Morgan, Beth;
Haughie, Scott;
Cavecchi, Alessandro;
Wiggenhorn, Christopher;
Beresford, Hayden;
Strickland, Helen;
Lyapustina, Svetlana

Publication type:

Article

A practical guide to the appropriate analysis of eGFR data over time: A simulation study.

Published in:

Pharmaceutical Statistics, 2024, v. 23, n. 5, p. 742, doi. 10.1002/pst.2381

By:

DeVries, Todd;
Carroll, Kevin J.;
Lewis, Sandra A.

Publication type:

Article

Conditional power and information fraction calculations at an interim analysis for random coefficient models.

Published in:

Pharmaceutical Statistics, 2024, v. 23, n. 2, p. 276, doi. 10.1002/pst.2345

By:

Lewis, Sandra A.;
Carroll, Kevin J.;
DeVries, Todd;
Barratt, Jonathan

Publication type:

Article

Coping with missing data in phase III pivotal registration trials: Tolvaptan in subjects with kidney disease, a case study.

Published in:

Pharmaceutical Statistics, 2017, v. 16, n. 4, p. 250, doi. 10.1002/pst.1808

By:

Ouyang, John;
Carroll, Kevin J.;
Koch, Gary;
Li, Junfang

Publication type:

Article

Back to basics: explaining sample size in outcome trials, are statisticians doing a thorough job?

Published in:

Pharmaceutical Statistics, 2009, v. 8, n. 4, p. 333, doi. 10.1002/pst.362

By:

Carroll, Kevin J.

Publication type:

Article

Biomarkers in drug development: friend or foe? A personal reflection gained working within oncology.

Published in:

Pharmaceutical Statistics, 2007, v. 6, n. 4, p. 253, doi. 10.1002/pst.269

By:

Carroll, Kevin J.

Publication type:

Article

Analysis of progression-free survival in oncology trials: some common statistical issues.

Published in:

Pharmaceutical Statistics, 2007, v. 6, n. 2, p. 99, doi. 10.1002/pst.251

By:

Carroll, Kevin J.

Publication type:

Article

Active-controlled, non-inferiority trials in oncology: arbitrary limits, infeasible sample sizes and uninformative data analysis. Is there another way?

Published in:

Pharmaceutical Statistics, 2006, v. 5, n. 4, p. 283, doi. 10.1002/pst.218

By:

Carroll, Kevin J.

Publication type:

Article

Improvement in wound healing, pain, and quality of life after 12 weeks of SNF472 treatment: a phase 2 open-label study of patients with calciphylaxis.

Published in:

Journal of Nephrology (JNonline), 2019, v. 32, n. 5, p. 811, doi. 10.1007/s40620-019-00631-0

By:

Brandenburg, Vincent M.;
Sinha, Smeeta;
Torregrosa, Jose-Vicente;
Garg, Rekha;
Miller, Stephan;
Canals, Ana-Zeralda;
Bahr, Daun;
Joubert, Pieter H.;
Salcedo, Carolina;
Carroll, Kevin J.;
Gold, Alex;
Perelló, Joan

Publication type:

Article

Comparisons of global tests on intersection hypotheses and their application in matched parallel gatekeeping procedures.

Published in:

Journal of Biopharmaceutical Statistics, 2020, v. 30, n. 4, p. 593, doi. 10.1080/10543406.2019.1696355

By:

Ouyang, John;
Zhang, Peter;
Carroll, Kevin J.;
Lee, Jennifer;
Koch, Gary

Publication type:

Article

Batch‐to‐Batch and Within‐Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?

Published in:

Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 2, p. 326, doi. 10.1002/cpt.1294

By:

Benet, Leslie Z.;
Jayachandran, Priya;
Carroll, Kevin J.;
Burmeister Getz, Elise

Publication type:

Article

A Perspective on the Appropriate Implementation of ICH E9(R1) Addendum Strategies for Handling Intercurrent Events.

Published in:

Statistics in Medicine, 2025, v. 44, n. 10-12, p. 1, doi. 10.1002/sim.70104

By:

Fleming, Thomas R.;
Carroll, Kevin J.;
Wittes, Janet T.;
Emerson, Scott S.;
Rothmann, Mark D.;
Collins, Sylva;
Levin, Gregory

Publication type:

Article

CALCIPHYX study: a randomized, double-blind, placebo-controlled, Phase 3 clinical trial of SNF472 for the treatment of calciphylaxis.

Published in:

Clinical Kidney Journal, 2022, v. 15, n. 1, p. 136, doi. 10.1093/ckj/sfab117

By:

Sinha, Smeeta;
Gould, Lisa J;
Nigwekar, Sagar U;
Serena, Thomas E;
Brandenburg, Vincent;
Moe, Sharon M;
Aronoff, George;
Chatoth, Dinesh K;
Hymes, Jeffrey L;
Miller, Stephan;
Padgett, Claire;
Carroll, Kevin J;
Perelló, Joan;
Gold, Alex;
Chertow, Glenn M

Publication type:

Article

Statistical Issues and Controversies in Active-Controlled, "Noninferiority" Trials.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 3, p. 229, doi. 10.1080/19466315.2013.786651

By:

Carroll, Kevin J.

Publication type:

Article

Statistical Evaluation and Analysis of Regional Interactions: The PLATO Trial Case Study.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 2, p. 91, doi. 10.1080/19466315.2013.783878

By:

Carroll, Kevin J.;
Fleming, Thomas R.

Publication type:

Article