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The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vimpat® | Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Change (CGI-C) at Month 6 | For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:
| Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures can be classified into one of the following three groups:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
In accordance with the Summary of Product Characteristics (SmPC)
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Patients with Partial-Onset Seizures not sufficiently controlled with one Baseline Antiepileptic Drug (AED), treated by Epilepsy centers, clinics or office-based neurologists with adjunctive Vimpat® in routine daily practice.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 55 | Aachen | Germany | ||||
| 119 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26526971 | Derived | Runge U, Arnold S, Brandt C, Reinhardt F, Kuhn F, Isensee K, Ramirez F, Dedeken P, Lauterbach T, Noack-Rink M, Mayer T. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3. |
| Label | URL |
|---|---|
| Product Information | View source |
Not provided
Participant Flow refers to the Enrolled Set (ES). The ES comprises all subjects who have been included in the observational study and for whom baseline examination data are available. Three patients were removed from the Enrolled Set after discussion in the Data Review Meeting.
This observational study started to enroll subjects in March 2010 in order to end up with 113 centers with enrolled subjects in Germany.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vimpat® | Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From Baseline to Month 3 |
| Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures can be classified into one of the following three groups:
| From Baseline to Month 6 |
| Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
| From Baseline to Month 3 |
| Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
| From Baseline to Month 6 |
| Incidence of Adverse Events During the Study | The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below. | From Inclusion Visit (Day 0) up to Month 6 |
| Aalen |
| Germany |
| 194 | Aichach | Germany |
| 191 | Altenburg | Germany |
| 136 | Alzenau in Unterfranken | Germany |
| 78 | Aschaffenburg | Germany |
| 35 | Bad Berka | Germany |
| 90 | Baesweiler | Germany |
| 107 | Berlin | Germany |
| 10A | Berlin | Germany |
| 141 | Berlin | Germany |
| 25 | Berlin | Germany |
| 49 | Berlin | Germany |
| 66 | Berlin | Germany |
| 75 | Berlin | Germany |
| 36 | Bielefeld | Germany |
| 5 | Bonn | Germany |
| 192 | Böblingen | Germany |
| 175 | Brandenburg | Germany |
| 105 | Chemnitz | Germany |
| 176 | Cologne | Germany |
| 180 | Cologne | Germany |
| 182 | Coppenbrügge | Germany |
| 161 | Dortmund | Germany |
| 128 | Dresden | Germany |
| 21 | Dresden | Germany |
| 39 | Dresden | Germany |
| 111 | Düren | Germany |
| 38 | Düsseldorf | Germany |
| 7 | Eberswalde | Germany |
| 102 | Eisenach | Germany |
| 174 | Eisenach | Germany |
| 56 | Ellwangen | Germany |
| 50 | Erbach im Odenwald | Germany |
| 179 | Erfurt | Germany |
| 186 | Erfurt | Germany |
| 6 | Erlangen | Germany |
| 12 | Essen | Germany |
| 27 | Freiburg im Breisgau | Germany |
| 137 | Fulda | Germany |
| 112 | Gelsenkirchen | Germany |
| 103 | Gera | Germany |
| 158 | Göttingen | Germany |
| 65 | Göttingen | Germany |
| 88 | Göttingen | Germany |
| 1 | Greifswald | Germany |
| 47 | Grevenbroich | Germany |
| 134 | Halle | Germany |
| 160 | Hamburg | Germany |
| 71 | Hamburg | Germany |
| 93 | Hamm | Germany |
| 147 | Heilbronn | Germany |
| 122 | Herborn | Germany |
| 15 | Herdecke | Germany |
| 130 | Höchberg | Germany |
| 40 | Immenstadt im Allgäu | Germany |
| 52 | Jena | Germany |
| 61 | Jülich | Germany |
| 44 | Karlstadt am Main | Germany |
| 133 | Kastellaun | Germany |
| 125 | Kaufbeuren | Germany |
| 16 | Kiel | Germany |
| 99 | Kleve | Germany |
| 37 | Krefeld | Germany |
| 46 | Lappersdorf | Germany |
| 113 | Leipzig | Germany |
| 4 | Leipzig | Germany |
| 68 | Leipzig | Germany |
| 81 | Leipzig | Germany |
| 138 | Lohr a. Main | Germany |
| 131 | Ludwigsburg | Germany |
| 148 | Lüdenscheid | Germany |
| 33 | Mainz | Germany |
| 154 | Mannheim | Germany |
| 151 | Mühlhausen | Germany |
| 101 | München | Germany |
| 167 | München | Germany |
| 2 | München | Germany |
| 43 | Neuburg am Inn | Germany |
| 62 | Neukirchen-Vluyn | Germany |
| 123 | Neumarkt | Germany |
| 69 | Nuremberg | Germany |
| 80 | Oelde | Germany |
| 98 | Oldenburg | Germany |
| 87 | Oranienburg | Germany |
| 57 | Potsdam | Germany |
| 3 | Radeberg | Germany |
| 159 | Rathenow | Germany |
| 45 | Ravensburg | Germany |
| 95 | Rostock | Germany |
| 85 | Rüsselsheim am Main | Germany |
| 20 | Schleswig | Germany |
| 157 | Schlüchtern | Germany |
| 166 | Schorndorf | Germany |
| 181 | Schriesheim | Germany |
| 150 | Schwäb. Gmünd | Germany |
| 168 | Schwedt | Germany |
| 140 | Senftenberg | Germany |
| 164 | Siegen | Germany |
| 144 | Sondershausen | Germany |
| 127 | Stralsund | Germany |
| 14 | Stuttgart | Germany |
| 170 | Stuttgart | Germany |
| 104 | Traunstein | Germany |
| 183 | Troisdorf | Germany |
| 17 | Tübingen | Germany |
| 13 | Ulm | Germany |
| 48 | Ulm | Germany |
| 54 | Unterhaching | Germany |
| 171 | Wermsdorf | Germany |
| 143 | Westerstede | Germany |
| 79 | Wismar | Germany |
| 169 | Wolfratshausen | Germany |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics refer to the Full Analysis Set (FAS) which comprises all patients who have been treated with Vimpat® at least once and for whom a valid value of seizure frequency is available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vimpat® | Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug. |
| 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 |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Clinical Global Impression of Change (CGI-C) at Month 6 | For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:
| Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure. FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available. | Posted | Number | participants | Month 6 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures can be classified into one of the following three groups:
| Of the 520 subjects in the Full Analysis Set (FAS), 449 subjects are included in the analysis of this outcome measure. FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available. | Posted | Mean | Standard Deviation | Seizures per 28 days | From Baseline to Month 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures can be classified into one of the following three groups:
| Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure. FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available. | Posted | Mean | Standard Deviation | Seizures per 28 days | From Baseline to Month 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
| Of the 520 subjects in the Full Analysis Set (FAS), 447 subjects are included in the analysis of this outcome measure. FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available. | Posted | Mean | Standard Deviation | Seizures per 28 days | From Baseline to Month 3 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
| Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure. FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available. | Posted | Mean | Standard Deviation | Seizures per 28 days | From Baseline to Month 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events During the Study | The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below. | All 571 subjects in the Safety Set are included in the analysis of this outcome measure. Safety Set comprises all patients included who have been treated with Vimpat® at least once. | Posted | Number | participants | From Inclusion Visit (Day 0) up to Month 6 |
|
|
Adverse Events were collected during the whole study from Inclusion Visit (Day 0) up to Month 6.
Adverse Events refer to the Safety Set, which comprises all enrolled subjects who have been treated with Vimpat at least once.
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 | Vimpat® | Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug. | 56 | 571 | 114 | 571 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Renal function test abnormal | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anaplastic astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Brain stem ischaemia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Postictal paralysis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Postictal state | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| > 18 years to <= 64 years |
|
| >= 65 years |
|
| Asiatic |
|
| Arabic |
|
| Black African |
|
| Other Race |
|
| Title | Measurements |
|---|---|
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Missing |
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|