Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group …
…, MFM Laurencin, G Bacher, B Holzhauer… - The Lancet …, 2016 - thelancet.com
Background Eosinophilic airway inflammation is often present in asthma, and reduction of
such inflammation results in improved clinical outcomes. We hypothesised that fevipiprant (…
such inflammation results in improved clinical outcomes. We hypothesised that fevipiprant (…
No evidence for a J-shaped curve in treated hypertensive patients with increased cardiovascular risk: The VALUE trial
…, FH Messerli, G Mancia, B Holzhauer… - Blood …, 2016 - Taylor & Francis
Previous studies have debated the notion that low blood pressure (BP) during treatment,
particularly diastolic (DBP), is associated with increased risk of cardiovascular disease. We …
particularly diastolic (DBP), is associated with increased risk of cardiovascular disease. We …
Safety and tolerability of canakinumab, an IL-1β inhibitor, in type 2 diabetes mellitus patients: a pooled analysis of three randomised double-blind studies
C Howard, A Noe, A Skerjanec, B Holzhauer… - Cardiovascular …, 2014 - Springer
Background We aimed to assess the safety and tolerability of different doses of canakinumab
versus placebo in patients with type 2 diabetes mellitus (T2DM). Methods Data were …
versus placebo in patients with type 2 diabetes mellitus (T2DM). Methods Data were …
Predicting drug approvals: The Novartis data science and artificial intelligence challenge
We describe a novel collaboration between academia and industry, an in-house data science
and artificial intelligence challenge held by Novartis to develop machine-learning models …
and artificial intelligence challenge held by Novartis to develop machine-learning models …
[HTML][HTML] Diagnostic performance of a machine learning algorithm (Asthma/Chronic Obstructive Pulmonary Disease [COPD] Differentiation Classification) tool versus …
JWH Kocks, H Cao, B Holzhauer, A Kaplan… - The Journal of Allergy …, 2023 - Elsevier
Background The differential diagnosis of asthma and chronic obstructive pulmonary disease
(COPD) poses a challenge in clinical practice and its misdiagnosis results in inappropriate …
(COPD) poses a challenge in clinical practice and its misdiagnosis results in inappropriate …
[HTML][HTML] Developing a short-term prediction model for asthma exacerbations from Swedish primary care patients' data using machine learning-Based on the ARCTIC …
…, M Łuczko, BK Bjerregaard, G Bacher, B Holzhauer… - Respiratory …, 2021 - Elsevier
Objective The ability to predict impending asthma exacerbations may allow better utilization
of healthcare resources, prevention of hospitalization and improve patient outcomes. We …
of healthcare resources, prevention of hospitalization and improve patient outcomes. We …
A new comprehensive approach to assess the probability of success of development programs before pivotal trials
LV Hampson, B Holzhauer, B Bornkamp… - Clinical …, 2022 - Wiley Online Library
The point at which clinical development programs transition from early phase to pivotal trials
is a critical milestone. Substantial uncertainty about the outcome of pivotal trials may remain …
is a critical milestone. Substantial uncertainty about the outcome of pivotal trials may remain …
Meta‐analysis of aggregate data on medical events
B Holzhauer - Statistics in medicine, 2017 - Wiley Online Library
Meta‐analyses of clinical trials often treat the number of patients experiencing a medical
event as binomially distributed when individual patient data for fitting standard time‐to‐event …
event as binomially distributed when individual patient data for fitting standard time‐to‐event …
Choice of estimand and analysis methods in diabetes trials with rescue medication
B Holzhauer, M Akacha, G Bermann - Pharmaceutical statistics, 2015 - Wiley Online Library
The analysis of clinical trials aiming to show symptomatic benefits is often complicated by
the ethical requirement for rescue medication when the disease state of patients worsens. In …
the ethical requirement for rescue medication when the disease state of patients worsens. In …
“Super‐covariates”: Using predicted control group outcome as a covariate in randomized clinical trials
B Holzhauer, ET Adewuyi - Pharmaceutical Statistics, 2023 - Wiley Online Library
The power of randomized controlled clinical trials to demonstrate the efficacy of a drug
compared with a control group depends not just on how efficacious the drug is, but also on the …
compared with a control group depends not just on how efficacious the drug is, but also on the …