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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Patients administrated remifentanil at the site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects are patients prescribed for Remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments | Posted | Number | participants | 24 hours |
|
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Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | WHOART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 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. | 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. | 24 hours |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. Gender data are missing for one participant. | Number | Participants |
|
| Race/Ethnicity, Customized | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. | Number | participants |
|
|
|
| Secondary | 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. | ITT Population | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | 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. | ITT Population | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | 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. | ITT Population | Posted | Number | participants | 24 hours |
|
|
|
| 0 |
| 766 |
| 187 |
| 766 |
| Bradyarrhythmia | Cardiac disorders | WHOART | Systematic Assessment |
|
| Premature ventricular contraction | Cardiac disorders | WHOART | Systematic Assessment |
|
| Gagging | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Tremor after operation | General disorders | WHOART | Systematic Assessment |
|
| Chest discomfort | General disorders | WHOART | Systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Skeletal muscle stiffness | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Dizziness | Nervous system disorders | WHOART | Systematic Assessment |
|
| Headache | Nervous system disorders | WHOART | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Sedation | Nervous system disorders | WHOART | Systematic Assessment |
|
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.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Headache |
|
| Dysuria |
|
| Coughing |
|
| Premature ventricular contraction |
|