Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children

NCT01297010 on ClinicalTrials.gov Phase 3 Instituto Materno Infantil Prof. Fernando Figueira (academic or other) Started 2011-03-31 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2011-07-31, after 2011-03-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2011-07-31. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: placebocontrolledrandomized doubledouble blindsurgical
Phrases that lowered it: dexamethasonecompareclinical trialagedstudy to
Accepts healthy volunteers: No (raises risk) · Who can join
Design: factorial (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Primary purpose: prevention (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 24.8% (raises risk) · Drug's FDA history
Responsible party: not given (raises risk) · Design
Drug's FAERS reports marked serious: 93.7% (raises risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Minimum age: 1 (lowers risk) · Who can join
Blinding: double (raises risk) · Design
Number of arms: 2 (raises risk) · Design
Drug's FAERS reports before start: 14541 (raises risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: factorial (typical: parallel)
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: not given (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 1 (typical: 18)
Maximum age: 10 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 6 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 3 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 14541 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4256 (typical: 412.5)
Drug's FAERS reports marked serious: 93.7% (typical: 85.6%)
Drug's FAERS reports with a death: 24.8% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: dexamethasone, dobesilate

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients NCT00828295 · started 2008 · scored riskier than 14% of active trials completed
Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy NCT05988671 · started 2023 · scored riskier than 7% of active trials completed
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients NCT01395901 · started 2011 · scored riskier than 30% of active trials completed
Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting NCT01975727 · started 2012 · scored riskier than 25% of active trials terminated
Midazolam Adjunct Therapy for Prevention of PONV in Gynecological Laparoscopy NCT07668700 · started 2025 · scored riskier than 12% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.