Trial Outcomes & Findings for Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation (NCT NCT02385526)
NCT ID: NCT02385526
Last Updated: 2018-07-23
Results Overview
Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame
Recruitment status
COMPLETED
Target enrollment
67 participants
Primary outcome timeframe
12 weeks post implant
Results posted on
2018-07-23
Participant Flow
Subjects enrolled at 15 clinical sites including university and private hospital clinics. Enrollment was allowed following successful initiation of the first clinical site on 04MAR2015 and closed on 29JUN2016. The first subject enrolled on 28APR2015 and the final two subjects enrolled on 29JUN2016. The final subject exited the study on 10OCT2016.
All subjects were required to receive implantation of a commercially available Vagus Nerve Stimulation generator (Stimulation of the left tenth cranial nerve via VNS Therapy) prior to randomization. The generator was to remain "off" until after randomization completion.
Participant milestones
| Measure |
Group A
Vagus Nerve Stimulation Therapy Standard Titration method
|
Group B
Vagus Nerve Stimulation Therapy Alternate Titration 1
Alternate titration method that combined methods from Group A and Group C.
|
Group C
Vagus Nerve Stimulation Therapy Alternate Titration 2
Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group A
Vagus Nerve Stimulation Therapy Standard Titration method
|
Group B
Vagus Nerve Stimulation Therapy Alternate Titration 1
Alternate titration method that combined methods from Group A and Group C.
|
Group C
Vagus Nerve Stimulation Therapy Alternate Titration 2
Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
Baseline characteristics by cohort
| Measure |
Group A
n=22 Participants
Vagus Nerve Stimulation Therapy Standard Titration method
|
Group B
n=20 Participants
Vagus Nerve Stimulation Therapy Alternate Titration 1
Alternate titration method that combined methods from Group A and Group C.
|
Group C
n=20 Participants
Vagus Nerve Stimulation Therapy Alternate Titration 2
Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
62 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post implantPopulation: Population of subjects implanted with Vagus Nerve Therapy generator who received stimulation via left, tenth cranial nerve at varying dosing methods (device settings adjustments) depending on the group each subject was randomized. All subject had a common, final target dose to achieve but used alternate methods to achieve the target dose.
Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame
Outcome measures
| Measure |
Group A
n=22 Participants
Vagus Nerve Stimulation Therapy Standard Titration method
|
Group B
n=20 Participants
Vagus Nerve Stimulation Therapy Alternate Titration 1
Alternate titration method that combined methods from Group A and Group C.
|
Group C
n=20 Participants
Vagus Nerve Stimulation Therapy Alternate Titration 2
Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction.
|
|---|---|---|---|
|
Percent Patients Reaching the Defined Target Dose
|
18 Participants
|
9 Participants
|
12 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group C
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=22 participants at risk
Vagus Nerve Stimulation Therapy Standard Titration method
|
Group B
n=20 participants at risk
Vagus Nerve Stimulation Therapy Alternate Titration 1
Alternate titration method that combined methods from Group A and Group C.
|
Group C
n=20 participants at risk
Vagus Nerve Stimulation Therapy Alternate Titration 2
Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction.
|
|---|---|---|---|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
Other adverse events
| Measure |
Group A
n=22 participants at risk
Vagus Nerve Stimulation Therapy Standard Titration method
|
Group B
n=20 participants at risk
Vagus Nerve Stimulation Therapy Alternate Titration 1
Alternate titration method that combined methods from Group A and Group C.
|
Group C
n=20 participants at risk
Vagus Nerve Stimulation Therapy Alternate Titration 2
Alternate titration method used in the ANTHEM-HF trial which evaluated the performance of autonomic regulation using VNS Therapy in patients with chronic symptomatic heart failure and reduced ejection fraction.
|
|---|---|---|---|
|
Cardiac disorders
Palpatations [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Ear and labyrinth disorders
Cerumen impaction [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Ear and labyrinth disorders
Tinnitus [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Gastrointestinal disorders
Constipation [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Gastrointestinal disorders
Diarrhoea [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Gastrointestinal disorders
Dysphagia [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Chest Pain [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Discomfort [S]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Fatigue [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Implant site hoematoma [I]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Medical device discomfort [S]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Medical device pain [S] [SI]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
General disorders
Non-cardiac chest pain [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Infections and infestations
Cellulitis [U]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Infections and infestations
Lower respiratory tract infection [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Infections and infestations
Nasopharyngitis [U]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Infections and infestations
Staphyloccal infection [I]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Infections and infestations
Urinary tract infection [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Injury, poisoning and procedural complications
Incision site haematoma [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Injury, poisoning and procedural complications
Incision site hypoaesthesia [I]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Injury, poisoning and procedural complications
Incision site pain [I]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
15.0%
3/20 • Number of events 4 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Injury, poisoning and procedural complications
Procedural headache [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Injury, poisoning and procedural complications
Procedural nausea [U]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Back pain [U]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness [SI]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching [S]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Myalgia [I]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Neck pain [I]
|
9.1%
2/22 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremety [I]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw [U] [S]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Nervous system disorders
Convulsion [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Nervous system disorders
Headache [U]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Nervous system disorders
Migraine [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Nervous system disorders
Paraesthesia [S]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Nervous system disorders
Postural tremor [S]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Nervous system disorders
Somnolence [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Psychiatric disorders
Anxiety [U] [SI]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma [U]
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Cough [S]
|
9.1%
2/22 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain [I] [S]
|
4.5%
1/22 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased [SI]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness [S]
|
9.1%
2/22 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Skin and subcutaneous tissue disorders
Pruritis [S]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
|
Vascular disorders
Peripheral arterial occlusive disease [U]
|
0.00%
0/22 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
0.00%
0/20 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected for the duration of each subjects study participation of 12 weeks. This period began from the first enrollment 28APR2015 to the final exit 10OCT2016.
Adverse reporting occurred via subject reporting and investigator assessment during the scheduled subject visits. Events related to epilepsy were not to be recorded unless a worsening from baseline was observed or experienced.
|
Additional Information
Peter Sears, Clinical Project Manager
Cyberonics, Inc.
Phone: (281) 228-7597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60