Evidence map›Paper›PMID 42338362›Full record

ArticleStatistics in medicine2026

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

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

Abstract readLetter
In one paragraph

Article in Statistics in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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

5 · Who and what money

Authors and funding

7 authors.

Thomas R FlemingDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-0420-5068
Kevin J CarrollKJC Statistics, LTD, Woodford, UK.
Janet T WittesWittes LLC, Washington, DC, USA.
Scott S EmersonDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.
Mark D RothmannOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Sylva CollinsOffice of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Gregory LevinOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

NIH HHS R37-AI29168
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

causal inferenceestimandsintercurrent eventsrandomization

Identifiers

PMID42338362
PMCPMC13291827

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.