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This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.
Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.
Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Requip PR | Experimental | Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Requip PR | Drug | Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. | From the start of treatment (Baseline) up to Week 25 |
| Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | An adverse event is defined as 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. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase. | From the start of treatment (Baseline) up to Week 25 |
| Number of Participants With an Adverse Event During the Follow-up Phase | AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guangzhou | Guangdong | 510120 | China | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25586298 | Derived | Zhang Z, Wang J, Zhang X, Chen S, Wang Z, Zhang B, Liu C, Qu Q, Cheng Y, Zhu R, Li J, Hu J, Cai M. An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease. Curr Med Res Opin. 2015 Apr;31(4):723-30. doi: 10.1185/03007995.2015.1005835. Epub 2015 Mar 12. |
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Participants who completed 24 weeks of randomized treatment in parent Study ROP111528 (NCT01154166) and 1 week of down titration at the end of treatment or at early withdraw were allowed to enter this extension study provided they had continued on study drug without a break.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
| FG001 | Placebo in Parent DB Study, Ropinirole PR in OL Study | Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. | Safety Population: all participants who received at least one dose of study drug | Posted | Number | Participants | From the start of treatment (Baseline) up to Week 25 |
|
AEs and SAEs are presented for the On-treatment Phase, including the Open-label Treatment Phase (24 weeks) and the Down-titration Phase (1 week) (up to Study Week 25).
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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 | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of Participants With the Indicated Adverse Events During the Follow-up Phase | An adverse event is defined as 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. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) |
| Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | An adverse event is defined as 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. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) |
| Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 |
| Wuhan |
| Hubei |
| 430022 |
| China |
| GSK Investigational Site | Suzhou | Jiangsu | 215004 | China |
| GSK Investigational Site | Xi'an | Shaanxi | 710061 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610041 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610072 | China |
| GSK Investigational Site | Kunming | Yunnan | 650032 | China |
| GSK Investigational Site | Kunming | Yunnan | 650101 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310009 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | 100050 | China |
| GSK Investigational Site | Beijing | 100053 | China |
| GSK Investigational Site | Beijing | 100730 | China |
| GSK Investigational Site | Beijing | 100853 | China |
| GSK Investigational Site | Shanghai | 200025 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Tianjin | 300052 | China |
| Lack of Efficacy |
|
| BG001 | Placebo in Parent DB Study, Ropinirole PR in OL Study | Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Duration of Parkinson's Disease | Mean | Standard Deviation | months |
|
Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
| OG001 | Placebo in Parent DB Study, Ropinirole PR in OL Study | Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. |
|
|
| Primary | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | An adverse event is defined as 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. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase. | Safety Population | Posted | Number | Participants | From the start of treatment (Baseline) up to Week 25 |
|
|
|
| Primary | Number of Participants With an Adverse Event During the Follow-up Phase | AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. | Safety Population | Posted | Number | Participants | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) |
|
|
|
| Primary | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | An adverse event is defined as 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. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. | Safety Population | Posted | Number | Participants | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) |
|
|
|
| Primary | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | An adverse event is defined as 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. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. | Safety Population | Posted | Number | Participants | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) |
|
|
|
| Secondary | Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 24 |
|
|
|
| 2 |
| 162 |
| 58 |
| 162 |
| EG001 | Placebo in Parent DB Study, Ropinirole PR in OL Study | Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. | 4 | 133 | 56 | 133 |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Retinal hemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Akinesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral ischemia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Meralgia paraesthetica | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Impulse-control disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
|
| Medication residue | General disorders | MedDRA | Systematic Assessment |
|
| Edema | General disorders | MedDRA | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Retinal hemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| Hypersensitvity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA | 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.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Somnolence |
|
| Akathisia |
|
| Akinesia |
|
| Cerebral infarction |
|
| Headache |
|
| Lethargy |
|
| Syncope |
|
| Nausea |
|
| Constipation |
|
| Abdominal distension |
|
| Abdominal pain upper |
|
| Epigastric discomfort |
|
| Flatulence |
|
| Vomiting |
|
| Hallucination |
|
| Insomnia |
|
| Hallucination, auditory |
|
| Impulse-control disorder |
|
| Oedema peripheral |
|
| Gait disturbance |
|
| Medication residue |
|
| Orthostatic hypotension |
|
| Hypotension |
|
| Lymphopenia |
|
| Arrhythmia |
|
| Blood uric acid increased |
|
| Weight decreased |
|
| Muscle spasms |
|
| Musculoskeletal stiffness |
|
| Vertigo |
|
| Decreased appetite |
|
| Asphyxia |
|
| Pruritus |
|
| Any SAE |
|
| Lymphopenia |
|
| Hallucination |
|
| Choking sensation |
|
| Hallucination |
|