Trial Outcomes & Findings for ULTIVA Post Marketing Surveillance (NCT NCT01299584)
NCT ID: NCT01299584
Last Updated: 2017-07-06
Results Overview
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.
COMPLETED
775 participants
24 hours
2017-07-06
Participant Flow
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.
Participant milestones
| Measure |
Ultiva 1, 2, or 3 mg
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Overall Study
STARTED
|
775
|
|
Overall Study
COMPLETED
|
766
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Ultiva 1, 2, or 3 mg
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Overall Study
Protocol Violation
|
9
|
Baseline Characteristics
ULTIVA Post Marketing Surveillance
Baseline characteristics by cohort
| Measure |
Ultiva 1, 2, or 3 mg
n=766 Participants
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Age, Continuous
|
45.3 Years
STANDARD_DEVIATION 16.5 • n=99 Participants
|
|
Sex/Gender, Customized
Female
|
422 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
343 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Korean
|
766 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Korean
|
0 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
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.
Outcome measures
| Measure |
Ultiva 1, 2, or 3 mg
n=766 Participants
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Number of Participants With an Unexpected Serious Adverse Event
Participants with unexpected SAEs
|
0 participants
|
|
Number of Participants With an Unexpected Serious Adverse Event
Participants with no unexpected SAEs
|
766 participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: ITT Population
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.
Outcome measures
| Measure |
Ultiva 1, 2, or 3 mg
n=766 Participants
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Number of Participants With an Adverse Event
|
187 participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: ITT Population
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.
Outcome measures
| Measure |
Ultiva 1, 2, or 3 mg
n=766 Participants
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Number of Participants With a Serious Adverse Event
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: ITT Population
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.
Outcome measures
| Measure |
Ultiva 1, 2, or 3 mg
n=766 Participants
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Number of Participants With the Indicated Unexpected Adverse Event
Premature ventricular contraction
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Event
Dizziness
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Event
Chest discomfort
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Event
Dyspepsia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Event
Headache
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Event
Dysuria
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Event
Coughing
|
1 participants
|
Adverse Events
Ultiva 1, 2, or 3 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultiva 1, 2, or 3 mg
n=766 participants at risk
One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
|
|---|---|
|
Cardiac disorders
Hypotension
|
16.1%
123/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Cardiac disorders
Bradyarrhythmia
|
13.7%
105/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Cardiac disorders
Premature ventricular contraction
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Gagging
|
2.5%
19/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
5/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
3/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Tremor after operation
|
1.0%
8/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Chest discomfort
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.65%
5/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Skeletal muscle stiffness
|
0.39%
3/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Dizziness
|
0.26%
2/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Headache
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Renal and urinary disorders
Dysuria
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Sedation
|
0.13%
1/766
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER