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Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Parkinson's Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirapex LA | Drug | Pramipexole Hydrochloride Hydrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Adverse Drug Reactions | Percentage of subjects with adverse drug reactions | From baseline up to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Effect | Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect. | Week 52 |
| Change From Baseline in Total Score of the UPDRS Part III to Last Observation |
Not provided
Inclusion criteria:
- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.
Exclusion criteria:
- None
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600
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 28 | Abiko,Chiba | Japan | ||||
| Boehringer Ingelheim Investigational Site 86 |
Not provided
This is an Observational study. Patients in the study have received only the standard treatment and no investigational drug was adminstered.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Parkinson's Disease (PD) | Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score.
UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status.
The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.
The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.
| Baseline and week 52 |
| Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement. | Baseline and week 52 |
| Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off". | Week 52 |
| Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication. | Week 52 |
| Akashi,Hyogo |
| Japan |
| Boehringer Ingelheim Investigational Site 13 | Akita,Akita | Japan |
| Boehringer Ingelheim Investigational Site 9 | Aomori,Aomori | Japan |
| Boehringer Ingelheim Investigational Site 2 | Asahikawa,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 36 | Bunkyo,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 35 | Chuo,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 40 | Chuo,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 54 | Chuo,Yamanashi | Japan |
| Boehringer Ingelheim Investigational Site 6 | Date,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 34 | Edogawa,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 32 | Fuchu,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 22 | Fujioka,Gunma | Japan |
| Boehringer Ingelheim Investigational Site 46 | Fujisawa,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 48 | Fujisawa,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 24 | Fukaya,Saitama | Japan |
| Boehringer Ingelheim Investigational Site 53 | Fukui,Fukui | Japan |
| Boehringer Ingelheim Investigational Site 105 | Fukuoka,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 106 | Fukuoka,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 109 | Fukuoka,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 16 | Fukushima,Fukushima | Japan |
| Boehringer Ingelheim Investigational Site 60 | Gifu,Gifu | Japan |
| Boehringer Ingelheim Investigational Site 44 | Hadano,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 62 | Hamamatsu,Shizuoka | Japan |
| Boehringer Ingelheim Investigational Site 96 | Hiroshima,Hiroshima | Japan |
| Boehringer Ingelheim Investigational Site 97 | Hiroshima,Hiroshima | Japan |
| Boehringer Ingelheim Investigational Site 78 | Ibaraki,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 29 | Ichihara,Chiba | Japan |
| Boehringer Ingelheim Investigational Site 68 | Ichinomiya,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 57 | Iida,Nagano | Japan |
| Boehringer Ingelheim Investigational Site 108 | Iiduka,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 88 | Ikoma,Nara | Japan |
| Boehringer Ingelheim Investigational Site 103 | Imabari,Ehime | Japan |
| Boehringer Ingelheim Investigational Site 17 | Iwaki,Fukushima | Japan |
| Boehringer Ingelheim Investigational Site 3 | Iwamizawa,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 117 | Kirishima,Kagoshima | Japan |
| Boehringer Ingelheim Investigational Site 111 | Kitakyushu,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 5 | Kitami,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 55 | Kofu,Yamanashi | Japan |
| Boehringer Ingelheim Investigational Site 70 | Konan,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 27 | Koshigaya,Saitama | Japan |
| Boehringer Ingelheim Investigational Site 114 | Kumamoto,Kumamoto | Japan |
| Boehringer Ingelheim Investigational Site 107 | Kurume,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 77 | Kyoto,Kyoto | Japan |
| Boehringer Ingelheim Investigational Site 23 | Maebashi,Gunma | Japan |
| Boehringer Ingelheim Investigational Site 42 | Minato,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 116 | Miyakonojo,Miyazaki | Japan |
| Boehringer Ingelheim Investigational Site 66 | Miyoshi,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 10 | Morioka,Iwate | Japan |
| Boehringer Ingelheim Investigational Site 74 | Moriyama,Shiga | Japan |
| Boehringer Ingelheim Investigational Site 4 | Muroran,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 56 | Nagano,Nagano | Japan |
| Boehringer Ingelheim Investigational Site 30 | Nagareyama,Chiba | Japan |
| Boehringer Ingelheim Investigational Site 113 | Nagasaki,Nagasaki | Japan |
| Boehringer Ingelheim Investigational Site 65 | Nagoya,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 67 | Nagoya,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 52 | Nanao,Ishikawa | Japan |
| Boehringer Ingelheim Investigational Site 104 | Nangoku,Kouchi | Japan |
| Boehringer Ingelheim Investigational Site 50 | Niigata,Niigata | Japan |
| Boehringer Ingelheim Investigational Site 85 | Nishinomiya,Hyogo | Japan |
| Boehringer Ingelheim Investigational Site 72 | Obu,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 61 | Ogaki,Gifu | Japan |
| Boehringer Ingelheim Investigational Site 92 | Ohta,Shimane | Japan |
| Boehringer Ingelheim Investigational Site 115 | Oita,Oita | Japan |
| Boehringer Ingelheim Investigational Site 93 | Okayama,Okayama | Japan |
| Boehringer Ingelheim Investigational Site 95 | Okayama,Okayama | Japan |
| Boehringer Ingelheim Investigational Site 118 | Okinawa,Okinawa | Japan |
| Boehringer Ingelheim Investigational Site 110 | Onojo,Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 80 | Osaka,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 81 | Osaka,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 82 | Osaka,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 38 | Ota,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 75 | Otsu,Shiga | Japan |
| Boehringer Ingelheim Investigational Site 76 | Otsu,Shiga | Japan |
| Boehringer Ingelheim Investigational Site 18 | Ryugasaki,Ibaragi | Japan |
| Boehringer Ingelheim Investigational Site 43 | Sagamihara,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 47 | Sagamihara,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 25 | Saitama,Saitama | Japan |
| Boehringer Ingelheim Investigational Site 26 | Saitama,Saitama | Japan |
| Boehringer Ingelheim Investigational Site 79 | Sakai,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 83 | Sakai,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 102 | Sakaide,Kagawa | Japan |
| Boehringer Ingelheim Investigational Site 58 | Saku,Nagano | Japan |
| Boehringer Ingelheim Investigational Site 31 | Sakura,Chiba | Japan |
| Boehringer Ingelheim Investigational Site 98 | Sanyōonoda | Japan |
| Boehringer Ingelheim Investigational Site 1 | Sapporo,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 7 | Sapporo,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 8 | Sapporo,Hokkaido | Japan |
| Boehringer Ingelheim Investigational Site 59 | Sekigahara,Gifu | Japan |
| Boehringer Ingelheim Investigational Site 11 | Sendai,Miyagi | Japan |
| Boehringer Ingelheim Investigational Site 12 | Sendai,Miyagi | Japan |
| Boehringer Ingelheim Investigational Site 33 | Setagaya,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 69 | Seto,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 63 | Shimoda,Shizuoka | Japan |
| Boehringer Ingelheim Investigational Site 64 | Shimoda,Shizuoka | Japan |
| Boehringer Ingelheim Investigational Site 99 | Shimonoseki,Yamaguchi | Japan |
| Boehringer Ingelheim Investigational Site 20 | Shimotsuke,Tochigi | Japan |
| Boehringer Ingelheim Investigational Site 21 | Shimotsuke,Tochigi | Japan |
| Boehringer Ingelheim Investigational Site 90 | Shingu,Wakayama | Japan |
| Boehringer Ingelheim Investigational Site 37 | Shinjuku,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 39 | Shinjuku,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 41 | Shinjuku,Tokyo | Japan |
| Boehringer Ingelheim Investigational Site 51 | Takaoka,Toyama | Japan |
| Boehringer Ingelheim Investigational Site 101 | Tokushima,Tokushima | Japan |
| Boehringer Ingelheim Investigational Site 112 | Tosu,Saga | Japan |
| Boehringer Ingelheim Investigational Site 71 | Toyokawa,Aichi | Japan |
| Boehringer Ingelheim Investigational Site 84 | Toyonaka,Osaka | Japan |
| Boehringer Ingelheim Investigational Site 87 | Toyooka,Hyogo | Japan |
| Boehringer Ingelheim Investigational Site 73 | Tsu,Mie | Japan |
| Boehringer Ingelheim Investigational Site 19 | Tsukuba,Ibaragi | Japan |
| Boehringer Ingelheim Investigational Site 94 | Tsukubo,Okayama | Japan |
| Boehringer Ingelheim Investigational Site 15 | Tsuruoka,Yamagata | Japan |
| Boehringer Ingelheim Investigational Site 89 | Wakayama,Wakayama | Japan |
| Boehringer Ingelheim Investigational Site 91 | Yazu,Tottori | Japan |
| Boehringer Ingelheim Investigational Site 45 | Yokohama,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 49 | Yokohama,Kanagawa | Japan |
| Boehringer Ingelheim Investigational Site 14 | Yokote,Akita | Japan |
| Boehringer Ingelheim Investigational Site 100 | Yoshinogawa,Tokushima | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety set: included all patients who had received treatment with Mirapex®-LA Tablets except those who were found to have no observation after enrolment, invalid registration, or invalid contract.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Parkinson's Disease (PD) | Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Adverse Drug Reactions | Percentage of subjects with adverse drug reactions | Safety set | Posted | Number | percentage of participants | From baseline up to week 52 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Effect | Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect. | Efficacy set: included all patients in the "safety set" except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease | Posted | Number | participants | Week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Score of the UPDRS Part III to Last Observation | Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia. | Efficacy set | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 52 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement. | Efficacy set | Posted | Mean | Standard Deviation | Units on a scale | Baseline and week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off". | Patients in safety set and with concomitant L-DOPA. | Posted | Number | participants | Week 52 |
|
| |||||||||||||||||||||||||||
| Secondary | Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication. | Patients in safety set and with concomitant L-DOPA | Posted | Number | participants | Week 52 |
|
|
From baseline upto Week 52.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Parkinson's Disease (PD) | Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg. | 30 | 569 | 35 | 569 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|