Trial Outcomes & Findings for Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug (NCT NCT01098162)

Last Updated: 2014-09-03

Results Overview

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: * Very much improved * Much improved * Minimally improved * No change * Minimally worse * Much worse * Very much worse

Recruitment status

COMPLETED

Target enrollment

576 participants

Primary outcome timeframe

Month 6

Results posted on

2014-09-03

Participant Flow

This observational study started to enroll subjects in March 2010 in order to end up with 113 centers with enrolled subjects in Germany.

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.

Participant milestones

Participant milestones
Measure	Vimpat® Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Overall Study STARTED	573
Overall Study COMPLETED	461
Overall Study NOT COMPLETED	112

Reasons for withdrawal

Reasons for withdrawal
Measure	Vimpat® Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Overall Study Adverse Event	37
Overall Study Lack of Efficacy	4
Overall Study Wish of Patient	7
Overall Study Lost to Follow-up	9
Overall Study Lack of Efficacy & Wish of Patient	5
Overall Study Adverse Event & Lack of Efficacy	6
Overall Study Adverse Event & Wish of Patient	13
Overall Study Adverse Event & Lost to Follow-up	2
Overall Study AE & Lack of Efficacy & Wish of Patient	1
Overall Study Wish of Patient & Lost to Follow-up	1
Overall Study Other Reason	1
Overall Study Reason Unknown	26

Baseline Characteristics

Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vimpat® n=520 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Age, Continuous	47.1 years STANDARD_DEVIATION 17.0 • n=5 Participants
Age, Customized < 16 years	0 participants n=5 Participants
Age, Customized >= 16 years to <= 18 years	7 participants n=5 Participants
Age, Customized > 18 years to <= 64 years	419 participants n=5 Participants
Age, Customized >= 65 years	94 participants n=5 Participants
Sex: Female, Male Female	264 Participants n=5 Participants
Sex: Female, Male Male	256 Participants n=5 Participants
Race/Ethnicity, Customized North/Middle European	484 participants n=5 Participants
Race/Ethnicity, Customized South European	28 participants n=5 Participants
Race/Ethnicity, Customized Asiatic	3 participants n=5 Participants
Race/Ethnicity, Customized Arabic	2 participants n=5 Participants
Race/Ethnicity, Customized Black African	0 participants n=5 Participants
Race/Ethnicity, Customized Other Race	3 participants n=5 Participants
Region of Enrollment Germany	520 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: 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.

Outcome measures

Outcome measures
Measure	Vimpat® n=515 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Clinical Global Impression of Change (CGI-C) at Month 6 Much Worse	9 participants
Clinical Global Impression of Change (CGI-C) at Month 6 Very Much Worse	2 participants
Clinical Global Impression of Change (CGI-C) at Month 6 Missing	11 participants
Clinical Global Impression of Change (CGI-C) at Month 6 Very Much Improved	160 participants
Clinical Global Impression of Change (CGI-C) at Month 6 Much Improved	179 participants
Clinical Global Impression of Change (CGI-C) at Month 6 Minimally Improved	66 participants
Clinical Global Impression of Change (CGI-C) at Month 6 No Change	72 participants
Clinical Global Impression of Change (CGI-C) at Month 6 Minimally Worse	16 participants

SECONDARY outcome

Timeframe: From Baseline to Month 3

Population: 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.

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: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

Outcome measures

Outcome measures
Measure	Vimpat® n=449 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3	-3.80 Seizures per 28 days Standard Deviation 26.23

SECONDARY outcome

Timeframe: From Baseline to Month 6

Population: 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.

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: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

Outcome measures

Outcome measures
Measure	Vimpat® n=500 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6	-4.24 Seizures per 28 days Standard Deviation 26.22

SECONDARY outcome

Timeframe: From Baseline to Month 3

Population: 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.

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: * Simple partial seizures evolving to generalized seizures * Complex partial seizures evolving to generalized seizures * Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.

Outcome measures

Outcome measures
Measure	Vimpat® n=447 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3	-0.39 Seizures per 28 days Standard Deviation 1.61

SECONDARY outcome

Timeframe: 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: * Simple partial seizures evolving to generalized seizures * Complex partial seizures evolving to generalized seizures * Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.

Outcome measures

Outcome measures
Measure	Vimpat® n=500 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6	-0.39 Seizures per 28 days Standard Deviation 1.88

SECONDARY outcome

Timeframe: From Inclusion Visit (Day 0) up to Month 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vimpat® n=571 Participants Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Incidence of Adverse Events During the Study	277 participants

Adverse Events

Vimpat®

Serious events: 56 serious events

Other events: 114 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vimpat® n=571 participants at risk Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Cardiac disorders Angina pectoris	0.35% 2/571 • Number of events 3 • 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.
Cardiac disorders Arrhythmia	0.18% 1/571 • Number of events 1 • 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.
Cardiac disorders Atrial fibrillation	0.18% 1/571 • Number of events 1 • 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.
Cardiac disorders Atrioventricular block second degree	0.18% 1/571 • Number of events 1 • 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.
Cardiac disorders Cardiac failure	0.18% 1/571 • Number of events 1 • 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.
Cardiac disorders Myocardial infarction	0.18% 1/571 • Number of events 1 • 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.
Cardiac disorders Ventricular fibrillation	0.18% 1/571 • Number of events 1 • 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.
Gastrointestinal disorders Haematemesis	0.18% 1/571 • Number of events 1 • 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.
Gastrointestinal disorders Nausea	0.18% 1/571 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	0.18% 1/571 • Number of events 1 • 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.
General disorders Asthenia	0.18% 1/571 • Number of events 1 • 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.
General disorders Gait disturbance	0.18% 1/571 • Number of events 1 • 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.
General disorders General physical health deterioration	0.18% 1/571 • Number of events 1 • 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.
Infections and infestations Appendicitis	0.18% 1/571 • Number of events 1 • 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.
Infections and infestations Clostridium difficile colitis	0.18% 1/571 • Number of events 1 • 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.
Infections and infestations Nasopharyngitis	0.18% 1/571 • Number of events 1 • 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.
Infections and infestations Pneumonia	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Fall	0.53% 3/571 • Number of events 3 • 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.
Injury, poisoning and procedural complications Ankle fracture	0.35% 2/571 • Number of events 2 • 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.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Concussion	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Drug toxicity	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Forearm fracture	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Joint dislocation	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Rib fracture	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Traumatic brain injury	0.18% 1/571 • Number of events 1 • 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.
Injury, poisoning and procedural complications Ulna fracture	0.18% 1/571 • Number of events 1 • 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.
Investigations Oxygen saturation decreased	0.18% 1/571 • Number of events 1 • 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.
Investigations Renal function test abnormal	0.18% 1/571 • Number of events 1 • 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.
Metabolism and nutrition disorders Dehydration	0.18% 1/571 • Number of events 1 • 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.
Metabolism and nutrition disorders Hyponatraemia	0.18% 1/571 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic astrocytoma	0.18% 1/571 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.18% 1/571 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.18% 1/571 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Convulsion	1.8% 10/571 • Number of events 11 • 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.
Nervous system disorders Grand mal convulsion	1.6% 9/571 • Number of events 10 • 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.
Nervous system disorders Epilepsy	1.2% 7/571 • Number of events 9 • 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.
Nervous system disorders Dizziness	0.88% 5/571 • Number of events 5 • 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.
Nervous system disorders Status epilepticus	0.70% 4/571 • Number of events 5 • 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.
Nervous system disorders Syncope	0.70% 4/571 • Number of events 4 • 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.
Nervous system disorders Brain stem ischaemia	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Cognitive disorder	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Disturbance in attention	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Headache	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Hemiparesis	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Nystagmus	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Partial seizures	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Postictal paralysis	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Postictal state	0.18% 1/571 • Number of events 1 • 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.
Nervous system disorders Speech disorder	0.18% 1/571 • Number of events 1 • 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.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.18% 1/571 • Number of events 1 • 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.
Psychiatric disorders Conversion disorder	0.53% 3/571 • Number of events 3 • 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.
Psychiatric disorders Disorientation	0.35% 2/571 • Number of events 2 • 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.
Psychiatric disorders Acute psychosis	0.18% 1/571 • Number of events 1 • 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.
Psychiatric disorders Confusional state	0.18% 1/571 • Number of events 1 • 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.
Psychiatric disorders Hallucination	0.18% 1/571 • Number of events 1 • 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.
Psychiatric disorders Hallucination, auditory	0.18% 1/571 • Number of events 1 • 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.
Psychiatric disorders Mood swings	0.18% 1/571 • Number of events 1 • 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.
Psychiatric disorders Suicidal ideation	0.18% 1/571 • Number of events 1 • 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.
Renal and urinary disorders Acute prerenal failure	0.18% 1/571 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.53% 3/571 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.18% 1/571 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 1/571 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.18% 1/571 • Number of events 1 • 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.
Vascular disorders Hypertensive crisis	0.35% 2/571 • Number of events 2 • 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.

Other adverse events

Other adverse events
Measure	Vimpat® n=571 participants at risk Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
General disorders Fatigue	12.4% 71/571 • Number of events 75 • 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.
Nervous system disorders Dizziness	10.5% 60/571 • Number of events 69 • 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.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60