Trial · NCT00625365
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
NCT00625365, Phase 4, Completed, Lantheus Medical Imaging; results first posted 2011-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice. Trials, record NCT00625365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00625365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
- NCT number
- NCT00625365
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,060 participants, actual
- Lead sponsor
- Lantheus Medical Imaging
- Conditions
- Cardiovascular Disease
- Interventions
- DEFINITY®
- First posted
- 2008-02-28
- Last updated
- 2020-11-24
- Results first posted
- 2011-01-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration | during or within 30 minutes of administration | |
| Secondary | Serious Adverse Events | Through 24 hours | Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration |
| Secondary | Adverse Events | Through 24 hours | Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration | during or within 30 minutes of administration | The safety population was analyzed per the protocol | Participants | NUMBER |
| SECONDARY | Serious Adverse Events | Through 24 hours | Participants | NUMBER | |
| SECONDARY | Adverse Events | Through 24 hours | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration | DEFINITY® | 0 | Participants | ||
| Serious Adverse Events | DEFINITY® | 0 | Participants | ||
| Adverse Events | DEFINITY® | 114 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DEFINITY® | 1,060 | |
| Overall Study | COMPLETED | DEFINITY® | 1,053 | |
| Overall Study | NOT COMPLETED | DEFINITY® | 7 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | DEFINITY® | 9 | 1,053 | 9 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | DEFINITY® | 7 | 1,053 | 7 |
| other | Headache | Nervous system disorders | DEFINITY® | 13 | 1,053 | 13 |
| other | Tremor | Nervous system disorders | DEFINITY® | 6 | 1,053 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DEFINITY® | ||
| Total, other adverse events | DEFINITY® | 35 | 1,053 |
| Total, serious adverse events | DEFINITY® | 0 | 1,053 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00625365
GET https://conductscience.org/api/trials/v1/NCT00625365/registered