An observational study in Analgesia, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by GlaxoSmithKline · Observational
This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing.
The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
The subjects are patients prescribed for Remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
Exclusion Criteria:
Patients administrated remifentanil at the site
Drug: Remifentanil
Basically there is no treatment allocation. Subjects who would be administered of remifentanil at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Number of Participants With an Unexpected Serious Adverse Event
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.
Time frame: 24 hours
Number of Participants With an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
Time frame: 24 hours
Number of Participants With a Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Time frame: 24 hours
Number of Participants With the Indicated Unexpected Adverse Event
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.
Time frame: 24 hours
The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Ultiva in the real clinical setting after launch.
| Milestone | Ultiva 1, 2, or 3 mg |
|---|---|
| Started | 775 |
| Completed | 766 |
| Not completed | 9 |
| Withdrew: Protocol violation | 9 |
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.
| participants | Ultiva 1, 2, or 3 mg |
|---|---|
| Participants with unexpected SAEs | 0 |
| Participants with no unexpected SAEs | 766 |
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
| participants | Ultiva 1, 2, or 3 mg |
|---|---|
| Number of Participants With an Adverse Event | 187 |
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
| participants | Ultiva 1, 2, or 3 mg |
|---|---|
| Number of Participants With a Serious Adverse Event | 0 |
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.
| participants | Ultiva 1, 2, or 3 mg |
|---|---|
| Dizziness | 1 |
| Chest discomfort | 1 |
| Dyspepsia | 1 |
| Headache | 1 |
| Dysuria | 1 |
| Coughing | 1 |
| Premature ventricular contraction | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultiva 1, 2, or 3 mg | — | 0/766 (0%) | 187/766 (24.4%) |
| Event | Ultiva 1, 2, or 3 mg |
|---|---|
| HypotensionCardiac disorders | 123/766 |
| BradyarrhythmiaCardiac disorders | 105/766 |
| GaggingGastrointestinal disorders | 19/766 |
| Tremor after operationGeneral disorders | 8/766 |
| VomitingGastrointestinal disorders | 5/766 |
| Respiratory depressionRespiratory, thoracic and mediastinal disorders | 5/766 |
| ConstipationGastrointestinal disorders | 3/766 |
| Skeletal muscle stiffnessMusculoskeletal and connective tissue disorders | 3/766 |
| DizzinessNervous system disorders | 2/766 |
| Premature ventricular contractionCardiac disorders | 1/766 |
| Age, Continuous(Years) | Ultiva 1, 2, or 3 mg |
|---|---|
| Mean | 45.3 ± 16.5 |
| Sex/Gender, Customized(Participants) | Ultiva 1, 2, or 3 mg |
|---|---|
| Female | 422 |
| Male | 343 |
| Race/Ethnicity, Customized(participants) | Ultiva 1, 2, or 3 mg |
|---|---|
| Korean | 766 |
| Not Korean | 0 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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