ICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies.

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

Who cites it

6 citing papers in PubMed.

1. Moxifloxacin-induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study.British journal of clinical pharmacology · 2015
   Trial
2. Improving In Silico Cardiac Safety Prediction by Consensus Averaging of Transmural Ventricular Cell Models.Annals of biomedical engineering · 2026
   Article
3. Prognostic value of index of cardiac electrophysiological balance among US middle-aged adults.Frontiers in cardiovascular medicine · 2023
   Article
4. Evaluation of Index of Cardio-Electrophysiological Balance (iCEB) as a New Biomarker for the Identification of Patients at Increased Arrhythmic Risk.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2016
   Article
5. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers.International journal of clinical pharmacology and therapeutics · 2015
   Article
6. Top-down, Bottom-up and Middle-out Strategies for Drug Cardiac Safety Assessment via Modeling and Simulations.Current pharmacology reports
   Review

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

Authors and funding

3 authors.

Funding

No grant is acknowledged in the PubMed record.

Abstract

PubMed holds no abstract for this paper.

Indexed as