Trial Outcomes & Findings for A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice (NCT NCT00625365)

NCT ID: NCT00625365

Last Updated: 2020-11-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1060 participants
• Primary outcome timeframe: during or within 30 minutes of administration
• Results posted on: 2020-11-24

Participant Flow

Participants were recruited from hospitals and clinics in the USA between February 2008 and April 2009

There were no pre-assignment requirements for this study

Participant milestones

Measure	DEFINITY® Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Overall Study STARTED	1060
Overall Study COMPLETED	1053
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	DEFINITY® Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Overall Study Withdrawal by Subject	1
Overall Study No IV access	5
Overall Study VSD	1

Baseline Characteristics

A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

Baseline characteristics by cohort

Measure	DEFINITY (Perflutren Lipid Microsphere) n=1053 Participants Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	609 Participants n=5 Participants
Age, Categorical >=65 years	444 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	400 Participants n=5 Participants
Sex: Female, Male Male	653 Participants n=5 Participants

PRIMARY outcome

Timeframe: during or within 30 minutes of administration

Population: The safety population was analyzed per the protocol

Outcome measures

Measure	DEFINITY® n=1053 Participants Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration	0 Participants

SECONDARY outcome

Timeframe: Through 24 hours

Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration

Outcome measures

Measure	DEFINITY® n=1053 Participants Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Through 24 hours

Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration

Outcome measures

Measure	DEFINITY® n=1053 Participants Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Adverse Events	114 Participants

Adverse Events

DEFINITY®

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DEFINITY® n=1053 participants at risk Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
Gastrointestinal disorders Nausea	0.85% 9/1053 • Number of events 9 • Through 24 hours post last dose
Musculoskeletal and connective tissue disorders Back Pain	0.66% 7/1053 • Number of events 7 • Through 24 hours post last dose
Nervous system disorders Headache	1.2% 13/1053 • Number of events 13 • Through 24 hours post last dose
Nervous system disorders Tremor	0.57% 6/1053 • Number of events 6 • Through 24 hours post last dose

Additional Information

Dana Washburn, M.D.

Lantheus Medical Imaging

Phone: 978-671-8686

Email: dana.washburn@lantheus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place