Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04266301 · MORE INFO

Limitations, agreements, and source contact

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement
other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
A total of 530 participants were randomized (265 to sabatolimab+AZA, 265 to placebo+AZA), but 1 participant in each arm did not receive any study treatment and were excluded from the Safety Set. Another sabatolimab-assigned participant received only AZA and thus was summarized in the placebo+AZA arm in all safety analyses. Therefore, the Serious and Other Adverse Events were shown for 263 sabatolimab+AZA and 265 placebo+AZA participants.
point Of Contact
email
novartis.email@novartis.com
organization
Novartis Pharmaceuticals
phone
862-778-3000
title
Study Director
Complete source fields
certain Agreement
other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
A total of 530 participants were randomized (265 to sabatolimab+AZA, 265 to placebo+AZA), but 1 participant in each arm did not receive any study treatment and were excluded from the Safety Set. Another sabatolimab-assigned participant received only AZA and thus was summarized in the placebo+AZA arm in all safety analyses. Therefore, the Serious and Other Adverse Events were shown for 263 sabatolimab+AZA and 265 placebo+AZA participants.
point Of Contact
email
novartis.email@novartis.com
organization
Novartis Pharmaceuticals
phone
862-778-3000
title
Study Director

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice