Currently submitted to: Journal of Medical Internet Research
Date Submitted: Jul 22, 2026
Open Peer Review Period: Jul 23, 2026 - Sep 17, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Impact of electronic monitoring of adverse events in patients receiving R-CHOP therapy for diffuse large B-cell lymphoma: open-label prospective randomized controlled phase 3 trial (EMILY)
ABSTRACT
Background:
Progression is the leading cause of death among patients receiving first line treatment for diffuse large B-cell lymphoma. Some patients die from treatment-related toxicity, secondary cancers, or comorbidities, particularly cardiovascular conditions. The early detection of these events could improve quality of life and event-free survival.
Objective:
This study aims to describe the adverse events that have occurred and the methods used to manage them, comparing an electronic application-assisted physician approach with standard follow-up procedures.
Methods:
An open-label prospective, randomized, controlled phase 3 trial was conducted to compare the impact of a web-based application for monitoring events occurring during rituximab combined with cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisone (R-CHOP) treatment (experimental group) with that of standard monitoring (control group).
Results:
A total of 62 patients were included in the study, with a median age of 62.0 years (Q1–Q3: 50.0–74.0). Thirty-one patients were randomized to each group (1:1 randomization). The study was terminated prematurely on October 17, 2024, due to bankruptcy of the unit responsible for promoting clinical trials. The median follow-up was 8.3 months (Q1–Q3: 1–24.2 months). In total, 617 events were reported (403 in the experimental group and 214 in the control group) (P<.01). About 340 events, including 238 in the experimental group and 102 in the control group, required intervention (P<.01). The median numbers of events per patient were 14 in the experimental group (Q1–Q3: 4–24), and 7 in the control group (Q1–Q3: 3–10) (P=.05). The mean times to treatment were 7.7 days in the overall population, 4.5 days in the experimental group, and 15.6 days in the control group (P=.14). Thirty-one events, including 13 in the experimental group and 18 in the control group, required hospitalization (P<.01). The event-free survival rates at the 12-months follow-up were 61.1% in the experimental group and 68.7% in the control group (P=.40).
Conclusions:
Event monitoring via a web application was feasible in patients with diffuse large B-cell lymphoma, with a higher number of reports in the experimental group. Compared with the control group, the experimental group had a lower proportion of events requiring hospitalization. However, considering the premature termination and the descriptive nature of the study, these results should be interpreted as exploratory Clinical Trial: ClinicalTrials.gov NCT05298293
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