NCT02662920

Brief Summary

Prevalence and prognostic significance of polypharmacy has not been evaluated in adults undergoing treatment for AML. Investigating the significance of polypharmacy in this population may help improve patient assessment and provide an opportunity to design simple interventions to minimize unnecessary morbidity associated with treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

3.7 years

First QC Date

January 19, 2016

Last Update Submit

June 29, 2018

Conditions

ACUTE MYELOGENOUS LEUKEMIA

Outcome Measures

Primary Outcomes (2)

  • Prevalence of polypharmacy in adults ≥60 years of age hospitalized for treatment of newly diagnosed AML

    Number of medications at baseline

    Day 1 (admission)

  • Prevalence of polypharmacy in adults ≥60 years of age hospitalized for treatment of newly diagnosed AML

    Number of medications at discharge

    Through hospitilization, an average of 30 days

Interventions

No InterventionOTHER

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults age ≥60 who received treatment while hospitalized for AML

You may qualify if:

  • Hospitalized between January 2004 and December 2009 with newly diagnosed AML
  • Age ≥60 years at the time of diagnosis
  • Received treatment while hospitalized for AML

You may not qualify if:

  • day mortality data unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 26, 2016

Study Start

August 1, 2010

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

July 2, 2018

Record last verified: 2018-06