Trial Outcomes & Findings for Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures (NCT NCT01118455)
NCT ID: NCT01118455
Last Updated: 2014-06-26
Results Overview
Responders are subjects who had no new AEDs added or significant dose changes in baseline AEDs within 1 year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
134 participants
Primary outcome timeframe
52 weeks post baseline
Results posted on
2014-06-26
Participant Flow
Subjects selected for participation in this clinical investigation were chosen from the investigator's general subject population or were referred by a physician who knew the subject well. They were selected for inclusion after consideration of the indications and contraindications of the device. Subjects were outpatients or inpatients.
Subjects were randomized to VNS or AED treatment groups at a 1:1 ratio after being stratified according to their number of previous AED treatments. Of 143 randomized 8 subjects were not treated. One subject (VNS arm) was explanted before device stimulation \& excluded. Therefore, 134 \[actual\] subjects were treated (ITT group): 65 (VNS), 69 (AED).
Participant milestones
| Measure |
Vagus Nerve Stimulation (VNS) - ITT Population
Vagus Nerve Stimulation (VNS) Therapy
|
Anti-Epileptic Drug (AED) - ITT Population
Anti-epileptic drug therapy
|
|---|---|---|
|
Baseline [Visits 1 & 2]
STARTED
|
66
|
69
|
|
Baseline [Visits 1 & 2]
Actual Patients Treated
|
65
|
69
|
|
Baseline [Visits 1 & 2]
COMPLETED
|
65
|
69
|
|
Baseline [Visits 1 & 2]
NOT COMPLETED
|
1
|
0
|
|
Treatment Phase (VNS/AED) [Visits 3-10]
STARTED
|
65
|
69
|
|
Treatment Phase (VNS/AED) [Visits 3-10]
COMPLETED
|
65
|
69
|
|
Treatment Phase (VNS/AED) [Visits 3-10]
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vagus Nerve Stimulation (VNS) - ITT Population
Vagus Nerve Stimulation (VNS) Therapy
|
Anti-Epileptic Drug (AED) - ITT Population
Anti-epileptic drug therapy
|
|---|---|---|
|
Baseline [Visits 1 & 2]
Adverse Event
|
1
|
0
|
Baseline Characteristics
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
Baseline characteristics by cohort
| Measure |
Vagus Nerve Stimulation (VNS) Therapy - ITT Population
n=65 Participants
Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED.
|
Anti-Epileptic Drug (AED) - ITT Population
n=69 Participants
This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.
The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
10.7 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Number of Failed Medications
|
6.0 Number of failed medications
FULL_RANGE 2.2 • n=5 Participants
|
6.0 Number of failed medications
FULL_RANGE 2.4 • n=7 Participants
|
6.0 Number of failed medications
FULL_RANGE 2.3 • n=5 Participants
|
|
Age at Epilepsy Onset (years)
|
2.4 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
2.7 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
2.6 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeks post baselinePopulation: Subjects were stratified based on AED therapy history (Early: treated with 2 to 5 AEDs versus Non-early: treated with \>5 AEDs).
Responders are subjects who had no new AEDs added or significant dose changes in baseline AEDs within 1 year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=23 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=33 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
n=23 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
n=25 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Proportion of Responders After 1 Year of Follow-up (ITT-population)
|
21.7 percentage of responders
129.1
|
39.4 percentage of responders
|
30.4 percentage of responders
90.9
|
24.0 percentage of responders
|
SECONDARY outcome
Timeframe: 52 weeks post baselineThe Hague Seizure Severity Assessment (Carpay et al. 1996) is a scale completed by the patient and/or caregiver to assess the severity and post-ictal recovery of seizures. A reduction in the HSSA score reflects less seizure severity experienced.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=25 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=32 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
n=24 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
n=27 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Mean Percent Change in Hague Seizure Severity Scale Score (ITT Population)
|
-1.8 Percent Change
Standard Deviation 19.1 • Interval -30.0 to 50.0
|
-7.7 Percent Change
Standard Deviation 20.3 • Interval -48.0 to 39.0
|
-11.9 Percent Change
Standard Deviation 17.1 • Interval -49.0 to 19.0
|
-1.4 Percent Change
Standard Deviation 17.7 • Interval -63.0 to 38.0
|
SECONDARY outcome
Timeframe: 52 weeks post baselineCalculate changes in the Wellcome Quality of Life Assessment (Parker et al. 1999) (Questionnaire A) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced. An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline. Total range for this scale is a minimum score of 81 to a maximum score of 336. There are no applicable subscales.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=12 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=17 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
n=9 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
n=17 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Wellcome Quality of Life Assessment (Questionnaire A) in Epilepsy (ITT Population)
|
26.7 Scores on a Scale
Standard Deviation 27.1
|
30.6 Scores on a Scale
Standard Deviation 48.5
|
17.0 Scores on a Scale
Standard Deviation 29.9
|
-2.1 Scores on a Scale
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: 52 weeks post baselineCalculate changes in the Hague Restriction in Childhood Epilepsy scale (Carpay et al. 1997) (Questionnaire B) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced. An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline. Total range for this scale is a minimum score of 10 to a maximum score of 40. There are no applicable subscales.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=14 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=18 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
n=17 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
n=12 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Hague Restriction in Childhood Epilepsy Scale (Questionnaire B) (ITT Population)
|
1.6 Scores on a Scale
Standard Deviation 5.6
|
3.0 Scores on a Scale
Standard Deviation 5.3
|
2.5 Scores on a Scale
Standard Deviation 7.6
|
1.3 Scores on a Scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 52 weeks post baselineThe mean percent change in seizure frequency for the VNS and AED treatment groups at 52 weeks post baseline. Both AED and VNS treatment groups were stratified according to the patients' number of previous AED treatments ("early group" had 2 to 5 AEDs tested to tolerance or to blood levels at upper end of target range; "non-early group" had more than 5 AEDs tested to tolerance or to blood levels at upper end of target range). Seizure frequency was calculated based on number of patient/caregiver reported seizures at 52-week post baseline (percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%). All seizures were counted. The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=23 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=33 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
n=23 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
n=25 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Mean Percent Change in Seizure Frequency (ITT Population)
|
28.6 Percent Change
Standard Deviation 177.5
|
-5.0 Percent Change
Standard Deviation 80.7
|
10.5 Percent Change
Standard Deviation 123.2
|
-17.3 Percent Change
Standard Deviation 43.3
|
SECONDARY outcome
Timeframe: 0-52 weeksPopulation: Number of participants with any definite related Adverse Event by body system and preferred term, Safety Population. NOTE: Number of participants analyzed in VNS arm includes one explant not from ITT population, but from safety population.
To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures. The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=66 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=69 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Investigations - weight decreased
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Blood and lymphatic system disorders
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Eye disorders
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Gastrointestinal disorders
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Ear and labyrinth disorders
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Infections and infestations
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Nervous system disorders
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Psychiatric disorders
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Respiratory and mediastinal disorders
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
General disorders & administration site conditions
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Injury, poisoning and procedural complications
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Metabolism and nutrition disorders
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)
Musculoskeletal & connective tissue disorders
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-52 weeksTo compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures. The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) - Early Group
n=66 Participants
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Vagus Nerve Stimulation (VNS) - Non-Early Group
n=69 Participants
Patients who were treated with \>5 AEDs prior to study entry who were randomized to VNS Therapy.
|
Anti-Epileptic Drug (AED) - Early Group
Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
|
Anti-Epileptic Drug (AED) - Non-Early Group
Patients who were treated with \>5 AEDs prior to study entry who were randomized to AED Group.
|
|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)
Injury, poisoning and procedural complications
|
0 participants
|
2 participants
|
—
|
—
|
|
Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)
Infections and infestations
|
1 participants
|
2 participants
|
—
|
—
|
|
Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)
Nervous system disorders
|
2 participants
|
7 participants
|
—
|
—
|
|
Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)
Skin and subcutaneous tissue disorders
|
1 participants
|
1 participants
|
—
|
—
|
|
Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)
Surgical and medical procedures
|
2 participants
|
5 participants
|
—
|
—
|
Adverse Events
Vagus Nerve Stimulation (VNS) Therapy - Safety Population
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Anti-Epileptic Drug (AED) - Safety Population
Serious events: 10 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vagus Nerve Stimulation (VNS) Therapy - Safety Population
n=66 participants at risk
Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.
NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population.
|
Anti-Epileptic Drug (AED) - Safety Population
n=69 participants at risk
This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.
All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment.
|
|---|---|---|
|
Infections and infestations
Tonsilitis
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Convulsion
|
3.0%
2/66 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
7.2%
5/69 • Number of events 5 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Surgical and medical procedures
Adenoidectomy
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Infections and infestations
Wound infection
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
2.9%
2/69 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Skin and subcutaneous tissue disorders
Stevens Johnson Syndrome
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
4.3%
3/69 • Number of events 3 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Surgical and medical procedures
Investigation
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Surgical and medical procedures
Medical device removal
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
Other adverse events
| Measure |
Vagus Nerve Stimulation (VNS) Therapy - Safety Population
n=66 participants at risk
Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.
NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population.
|
Anti-Epileptic Drug (AED) - Safety Population
n=69 participants at risk
This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.
All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Ear and labyrinth disorders
External ear disorder
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Gastrointestinal disorders
Abdonimal pain
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
2.9%
2/69 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
General disorders
Fatigue
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
General disorders
Localised oedema
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
General disorders
Medical device pain
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Infections and infestations
Influenza
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Infections and infestations
Viral infection
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Infections and infestations
Wound infection
|
3.0%
2/66 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Investigations
Weight decreased
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
2/66 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
2.9%
2/69 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Convulsion
|
3.0%
2/66 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
5.8%
4/69 • Number of events 4 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Dysarthia
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Grand mal convulsion
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Headache
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Myoclonus
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.0%
2/66 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Sedation
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
2.9%
2/69 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Somnolence
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Nervous system disorders
Speech disorder
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Psychiatric disorders
Abnormal behavior
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
4.3%
3/69 • Number of events 3 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Psychiatric disorders
Sleep disorder
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
2/66 • Number of events 2 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.5%
1/66 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
0.00%
0/69 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/66 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
1.4%
1/69 • Number of events 1 • 0-52 Weeks (1-Year)
The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm. Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population.
|
Additional Information
Mark Bunker, PharmD, Sr. Director, Global Medical Affairs
Cyberonics, Inc.
Phone: 281-228-7223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60