Trial Outcomes & Findings for Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair (NCT NCT04774328)

Last Updated: 2022-09-14

Results Overview

Pain at rest measured by a Numeric Rating Scale (NRS) from time 0 to 96 hours (AUC 0-96). NRS pain scores at rest were collected at 1, 2, 4, 6, 8, 12, 16, 20, 24 and every 4 hours there after post the time of entry into the PACU (while the patient is awake), until discharge from the inpatient until at 96 hour. NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Up to 96 hours

Results posted on

2022-09-14

Participant Flow

The clinical trial was conducted at one clinical research surgical center from September 2020 until June 2021. Qualified patients are adults aged 18 to 80 years of age, inclusive, who are planning to undergo an elective, open laparotomy for ventral hernia repair (VHR), with retromuscular, preperitoneal mesh repair and who otherwise meet eligibility criteria.

Sixty-seven patients were screened. Ten met requirements for open-label Part A and 24 were randomized to Part B. Patients meeting all inclusion and no exclusion criteria underwent VHR surgery and dosing on Day 1. The patient was closely followed during the outpatient portion to Day 29 post surgery. Part A began enrolling in September 2020 and Part B on 10FEB2021. Part C was not conducted due to a corporate decision, and not due to any safety concerns.

Participant milestones

Participant milestones
Measure	CA-008 (Vocacapsaicin), 15 mg - Part A Single administration of CA-008 (vocacapsaicin), 15 mg (50 ml of a 0.3 mg/mL solution) Open-label, feasibility and safety assessment, exploration of different delivery techniques	CA-008 (Vocacapsaicin), 24 mg - Part B CA-008 (vocacapsaicin): single administration of CA-008 (vocacapsaicin), 24 mg (80 ml of a 0.3 mg/mL solution) Double-blind, randomized, placebo-controlled, parallel-group design.	Placebo - Part B Single administration of placebo Double-blind, randomized, placebo-controlled, parallel-group design.
Overall Study STARTED	10	12	12
Overall Study Follow-up to 29 Days Post Surgery	10	12	12
Overall Study COMPLETED	10	12	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CA-008 (Vocacapsaicin), 15 mg - Part A n=10 Participants Single administration of CA-008 (vocacapsaicin), 15 mg (50 ml of a 0.3 mg/mL solution)	CA-008 (Vocacapsaicin), 24 mg - Part B n=12 Participants Single administration of CA-008 (vocacapsaicin), 24 mg (80 ml of a 0.3 mg/mL solution)	Placebo - Part B n=12 Participants Single administration of placebo	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	47.9 years STANDARD_DEVIATION 10.8 • n=5 Participants	47.1 years STANDARD_DEVIATION 10.16 • n=7 Participants	42.2 years STANDARD_DEVIATION 10.19 • n=5 Participants	45.6 years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	34 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 96 hours

Population: modified Intent to Treat (mITT) population

Outcome measures

Outcome measures
Measure	CA-008 (Vocacapsaicin), 24 mg - Part B n=12 Participants Single administration of CA-008 (vocacapsaicin), at a fixed dose of 24 mg (80 mL of a 0.3 mg/mL concentration)	Placebo - Part B n=12 Participants Single administration of placebo
Pain at Rest - Part B	148.98 score on a scale*hours Standard Deviation 146.68	188.26 score on a scale*hours Standard Deviation 120.60

SECONDARY outcome

Timeframe: Up to 96 hours

Population: modified Intent to Treat (mITT) population

Evoked NRS pain scores (three maneuvers: coughing, sitting up, walking) from time 0-96 hours. Evoked NRS scores were obtained twice daily in the morning at 10:00AM (± 1h) and in the afternoon at 4:00PM (±1 h). NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.

Outcome measures

Outcome measures
Measure	CA-008 (Vocacapsaicin), 24 mg - Part B n=12 Participants Single administration of CA-008 (vocacapsaicin), at a fixed dose of 24 mg (80 mL of a 0.3 mg/mL concentration)	Placebo - Part B n=12 Participants Single administration of placebo
Evoked NRS - Part B Sitting-up	116.24 score on a scale*hours Standard Deviation 105.90	171.28 score on a scale*hours Standard Deviation 105.69
Evoked NRS - Part B After ambulation	143.42 score on a scale*hours Standard Deviation 112.71	222.14 score on a scale*hours Standard Deviation 94.89
Evoked NRS - Part B Coughing	187.58 score on a scale*hours Standard Deviation 176.49	345.66 score on a scale*hours Standard Deviation 135.50

SECONDARY outcome

Timeframe: Up to Day 8

Population: modified Intent to Treat (mITT) population

Total opioid consumption (OC) converted to an oral morphine equivalent (OME) dose from 0 to 96 hours (OC 0-T96) and 0 to Day 8 (OC 0-D8).

Outcome measures

Outcome measures
Measure	CA-008 (Vocacapsaicin), 24 mg - Part B n=12 Participants Single administration of CA-008 (vocacapsaicin), at a fixed dose of 24 mg (80 mL of a 0.3 mg/mL concentration)	Placebo - Part B n=12 Participants Single administration of placebo
Opioid Consumption - Part B OC 0 to 96 hours	27.18 mg morphine equivalents Standard Deviation 31.63	36.56 mg morphine equivalents Standard Deviation 30.70
Opioid Consumption - Part B OC 0 to Day 8	29.68 mg morphine equivalents Standard Deviation 37.66	37.81 mg morphine equivalents Standard Deviation 33.27

Adverse Events

CA-008 (Vocacapsaicin), 15 mg - Part A

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

CA-008 (Vocacapsaicin), 24 mg - Part B

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo - Part B

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Carrie Khouri, Associate Director of Clinical Operations

Concentric Analgesics

Phone: 1-415-484-7921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure restriction on the PI and/or institution: 1. Sponsor can embargo communications or publications regarding trial results for more than 60 days but less than 181 days from the time submitted to the sponsor. The sponsor cannot extend the embargo. 2. The Institution and Investigator agree that any Institutional Publication shall be made after the Multicenter Publication, provided that the Multicenter Publication is submitted within eighteen (18) months after conclusion of the Study.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	CA-008 (Vocacapsaicin), 15 mg - Part A n=10 participants at risk Single administration of CA-008 (vocacapsaicin), 15 mg (50 ml of a 0.3 mg/mL solution)	CA-008 (Vocacapsaicin), 24 mg - Part B n=12 participants at risk Single administration of CA-008 (vocacapsaicin), 24 mg (80 ml of a 0.3 mg/mL solution)	Placebo - Part B n=12 participants at risk Single administration of placebo
Cardiac disorders Bradycardia	10.0% 1/10 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Cardiac disorders Tachycardia	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	25.0% 3/12 • Number of events 3 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	16.7% 2/12 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Abdominal discomfort	10.0% 1/10 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Constipation	60.0% 6/10 • Number of events 6 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	50.0% 6/12 • Number of events 6 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	66.7% 8/12 • Number of events 8 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Flatulence	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	33.3% 4/12 • Number of events 4 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Gastrointestinal disorders Vomiting	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	16.7% 2/12 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
General disorders Chest pain	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
General disorders Discomfort	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Immune system disorders Hypersensitivity	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Infections and infestations Postoperative wound infection	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	16.7% 2/12 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Injury, poisoning and procedural complications Incision site rash	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Injury, poisoning and procedural complications Incision site vesicles	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	16.7% 2/12 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Injury, poisoning and procedural complications Post procedural haemorrhage	10.0% 1/10 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Investigations Blood Pressure Increased	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	16.7% 2/12 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Respiratory, thoracic and mediastinal disorders Tachypenoea	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Skin and subcutaneous tissue disorders Blister	10.0% 1/10 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
Vascular disorders Hypertension	0.00% 0/10 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	0.00% 0/12 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).	8.3% 1/12 • Number of events 1 • All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery. The definition of adverse events is consistent with clinicaltrials.gov definitions. Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).