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Efficacy and safety of givosiran for acute hepatic porphyria: 24‐month interim analysis of the randomized phase 3 ENVISION study

Liver international, 2022-01, Vol.42 (1), p.161-172

2022

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S1063 Disease Burden in Patients With Acute Hepatic Porphyria: Experience From the Phase 3 ENVISION Study

The American journal of gastroenterology, 2021-10, Vol.116 (1), p.S504-S504

2021

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S1170 Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyria: 24-Month Interim Analysis of the Phase 3 ENVISION Randomized Clinical Trial

The American journal of gastroenterology, 2021-10, Vol.116 (1), p.S545-S546

2021

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S1171 EXPLORE Part B: A Prospective, International, Long-Term Natural History Study of Patients With Acute Hepatic Porphyria With Recurrent Symptoms

The American journal of gastroenterology, 2021-10, Vol.116 (1), p.S546-S546

2021

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Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study

Journal of hematology and oncology, 2017-07, Vol.10 (1), p.137-13, Article 137

2017

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Asia‐inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial

Clinical and translational science, 2021-05, Vol.14 (3), p.1069-1081

2021

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Adaptive Three-Stage Clinical Trial Design for a Binary Endpoint in the Rare Disease Setting

Pharmaceutical Statistics, p.167-180

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Pevonedistat (MLN4924), a First‐in‐Class NEDD8‐activating enzyme inhibitor, in patients with acute myeloid leukaemia and myelodysplastic syndromes: a phase 1 study

British journal of haematology, 2015-05, Vol.169 (4), p.534-543

2015

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Phase 3 study of first line pevonedistat (PEV) + azacitidine (AZA) versus single-agent AZA in patients with higher-risk myelodysplastic syndromes (HR MDS), chronic myelomonocytic leukemia (CMML) or low-blast acute myelogenous leukemia (AML)

Journal of clinical oncology, 2018-05, Vol.36 (15_suppl), p.TPS7077-TPS7077

2018

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Longitudinal trends in health-related quality of life (HRQoL) among patients treated with ivosidenib (IVO) for IDH1 -mutated cholangiocarcinoma (CCA) in the ClarIDHy study

Journal of clinical oncology, 2022-02, Vol.40 (4_suppl), p.388-388

2022

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Phase I Study of the Novel Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (MLN4924) in Patients with Relapsed/Refractory Multiple Myeloma or Lymphoma

Clinical cancer research, 2016-01, Vol.22 (1), p.34-43

2016

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Pharmacokinetics/pharmacodynamics of ivosidenib in advanced IDH1-mutant cholangiocarcinoma: findings from the phase III ClarIDHy study

Cancer chemotherapy and pharmacology, 2024-05, Vol.93 (5), p.471-479

2024

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Zmax test for delayed effect in immuno-oncology clinical trials

Journal of biopharmaceutical statistics, 2020-03, Vol.30 (2), p.244-266

2020

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Neuroinflammation, hyperphosphorylated tau, diffuse amyloid plaques, and down-regulation of the cellular prion protein in air pollution exposed children and young adults

Journal of Alzheimer's disease, 2012, Vol.28 (1), p.93

2012

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Z max test for delayed effect in immuno-oncology clinical trials

Journal of biopharmaceutical statistics, 2020-03, Vol.30 (2), p.244-266

2020

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Inside Front Cover

Liver international, 2022-01, Vol.42 (1)

2022

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Inside Front Cover

Liver international, 2022-01, Vol.42 (1), p.ii-ii

2022

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Model‐Based Meta‐Analysis for Multiple Myeloma: A Quantitative Drug‐Independent Framework for Efficient Decisions in Oncology Drug Development

Clinical and translational science, 2018-03, Vol.11 (2), p.218-225

2018

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Interleukin‐1β induces β‐calcitonin gene‐related peptide secretion in human type II alveolar epithelial cells

The FASEB journal, 2004-10, Vol.18 (13), p.1603-1605

2004

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Pevonedistat ( MLN 4924), a First‐in‐Class NEDD 8‐activating enzyme inhibitor, in patients with acute myeloid leukaemia and myelodysplastic syndromes: a phase 1 study

British journal of haematology, 2015-05, Vol.169 (4), p.534-543

2015

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Pevonedistat (MLN4924), an Investigational, First-in-Class NAE Inhibitor, in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) Considered Unfit for Conventional Chemotherapy: Updated Results from the Phase 1 C15009 Trial

Blood, 2014-12, Vol.124 (21), p.2313-2313

2014

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Semiparametric Bayes Local Additive Models for Longitudinal Data

Statistics in biosciences, 2015-05, Vol.7 (1), p.90-107

2015

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Semiparametric Bayesian local functional models for diffusion tensor tract statistics

NeuroImage (Orlando, Fla.), 2012-10, Vol.63 (1), p.460-474

2012

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MLN4924, a Novel Investigational Inhibitor Of NEDD8-Activating Enzyme (NAE), In Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS): Results From Multiple Dosing Schedules In a Phase 1 Study

Blood, 2013-11, Vol.122 (21), p.1443-1443

2013

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Efficacy and safety of givosiran for acute hepatic porphyria: 24‐month interim analysis of the randomized phase 3 ENVISION study

S1063 Disease Burden in Patients With Acute Hepatic Porphyria: Experience From the Phase 3 ENVISION Study

S1170 Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyria: 24-Month Interim Analysis of the Phase 3 ENVISION Randomized Clinical Trial

S1171 EXPLORE Part B: A Prospective, International, Long-Term Natural History Study of Patients With Acute Hepatic Porphyria With Recurrent Symptoms

Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study

Asia‐inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial

Adaptive Three-Stage Clinical Trial Design for a Binary Endpoint in the Rare Disease Setting

Pevonedistat (MLN4924), a First‐in‐Class NEDD8‐activating enzyme inhibitor, in patients with acute myeloid leukaemia and myelodysplastic syndromes: a phase 1 study

Phase 3 study of first line pevonedistat (PEV) + azacitidine (AZA) versus single-agent AZA in patients with higher-risk myelodysplastic syndromes (HR MDS), chronic myelomonocytic leukemia (CMML) or low-blast acute myelogenous leukemia (AML)

Longitudinal trends in health-related quality of life (HRQoL) among patients treated with ivosidenib (IVO) for IDH1 -mutated cholangiocarcinoma (CCA) in the ClarIDHy study

Phase I Study of the Novel Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (MLN4924) in Patients with Relapsed/Refractory Multiple Myeloma or Lymphoma

Pharmacokinetics/pharmacodynamics of ivosidenib in advanced IDH1-mutant cholangiocarcinoma: findings from the phase III ClarIDHy study

Zmax test for delayed effect in immuno-oncology clinical trials

Neuroinflammation, hyperphosphorylated tau, diffuse amyloid plaques, and down-regulation of the cellular prion protein in air pollution exposed children and young adults

Z max test for delayed effect in immuno-oncology clinical trials

Inside Front Cover

Inside Front Cover

Model‐Based Meta‐Analysis for Multiple Myeloma: A Quantitative Drug‐Independent Framework for Efficient Decisions in Oncology Drug Development

The ECHELON-2 Trial: Results of a Randomized, Double-Blind, Active-Controlled Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients with CD30+ Peripheral T-Cell Lymphomas

Interleukin‐1β induces β‐calcitonin gene‐related peptide secretion in human type II alveolar epithelial cells

Pevonedistat ( MLN 4924), a First‐in‐Class NEDD 8‐activating enzyme inhibitor, in patients with acute myeloid leukaemia and myelodysplastic syndromes: a phase 1 study

Pevonedistat (MLN4924), an Investigational, First-in-Class NAE Inhibitor, in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) Considered Unfit for Conventional Chemotherapy: Updated Results from the Phase 1 C15009 Trial

Semiparametric Bayes Local Additive Models for Longitudinal Data

Semiparametric Bayesian local functional models for diffusion tensor tract statistics

MLN4924, a Novel Investigational Inhibitor Of NEDD8-Activating Enzyme (NAE), In Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS): Results From Multiple Dosing Schedules In a Phase 1 Study

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