Trial Outcomes & Findings for Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis (NCT NCT01475253)

NCT ID: NCT01475253

Last Updated: 2015-09-21

Results Overview

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 104 participants
• Primary outcome timeframe: Baseline, Day 7
• Results posted on: 2015-09-21

Participant Flow

Study subjects were recruited by clinical centers that saw subjects meeting eligibility criteria and were capable of undergoing cystoscopy per protocol specifications. The first subject was enrolled 28 November 2011.

In addition to meeting all protocol defined inclusion/exclusion criteria, participants were required to be females with a confirmed diagnosis of moderate to severe Interstitial Cystitis (IC) according to the 1987 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) symptom severity criteria (modified to exclude cystometry).

Participant milestones

Measure	LiRIS® 400 mg - Randomized Study LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	Sham Cystoscopic Procedure-Randomized Study Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.	LiRIS® 400 mg - Open Label Extension LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
Randomized, Blinded Study STARTED	47	46	11	0
Randomized, Blinded Study COMPLETED	45	45	11	0
Randomized, Blinded Study NOT COMPLETED	2	1	0	0
Open Label Extension STARTED	0	0	0	56
Open Label Extension COMPLETED	0	0	0	56
Open Label Extension NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Measure	LiRIS® 400 mg - Randomized Study LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	Sham Cystoscopic Procedure-Randomized Study Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.	LiRIS® 400 mg - Open Label Extension LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
Randomized, Blinded Study Withdrawal by Subject	1	1	0	0
Randomized, Blinded Study Lost to Follow-up	1	0	0	0

Baseline Characteristics

Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

Baseline characteristics by cohort

Measure	LiRIS® 400 Mg-Randomized Study n=47 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=46 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	Sham Cystoscopic Procedure-Randomized Study n=11 Participants Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.	Total n=104 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	42 Participants n=5 Participants	39 Participants n=7 Participants	11 Participants n=5 Participants	92 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants
Age, Continuous	44.4 years STANDARD_DEVIATION 14.76 • n=5 Participants	45.9 years STANDARD_DEVIATION 15.85 • n=7 Participants	38.1 years STANDARD_DEVIATION 12.90 • n=5 Participants	44.4 years STANDARD_DEVIATION 15.12 • n=4 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	46 Participants n=7 Participants	11 Participants n=5 Participants	104 Participants n=4 Participants
Sex: Female, Male Male	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	44 participants n=5 Participants	44 participants n=7 Participants	11 participants n=5 Participants	99 participants n=4 Participants
Region of Enrollment Canada	3 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=42 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7	-1.25 centimeters Standard Deviation 2.45	-0.84 centimeters Standard Deviation 1.92

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=42 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14	-0.81 centimeters Standard Deviation 2.50	-0.45 centimeters Standard Deviation 2.45

PRIMARY outcome

Timeframe: Baseline, Day 28

Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=42 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28	-0.92 centimeters Standard Deviation 2.36	-1.36 centimeters Standard Deviation 2.28

PRIMARY outcome

Timeframe: Baseline, Day 42

Population: Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=42 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42	-0.89 centimeters Standard Deviation 2.58	-1.40 centimeters Standard Deviation 2.51

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28 and 42

Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=42 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Percentage of Responders Using the Global Response Assessment (GRA) Day 7	24 Percentage of Responders	18 Percentage of Responders
Percentage of Responders Using the Global Response Assessment (GRA) Day 14	17 Percentage of Responders	20 Percentage of Responders
Percentage of Responders Using the Global Response Assessment (GRA) Day 28	7 Percentage of Responders	25 Percentage of Responders
Percentage of Responders Using the Global Response Assessment (GRA) Day 42	12 Percentage of Responders	21 Percentage of Responders

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28 and 42

Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words "No Urgency" (best) at the left end (0 cm) and the words "Urgency as bad as you can imagine" (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=43 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Urinary Urgency as Assessed by VAS Change from Baseline at Day 7	0.66 centimeters Standard Deviation 2.66	-1.45 centimeters Standard Deviation 2.69
Change From Baseline in Urinary Urgency as Assessed by VAS Change from Baseline at Day 14	-0.76 centimeters Standard Deviation 3.14	-1.00 centimeters Standard Deviation 2.74
Change From Baseline in Urinary Urgency as Assessed by VAS Change from Baseline at Day 28	-1.01 centimeters Standard Deviation 2.93	-1.77 centimeters Standard Deviation 2.70
Change From Baseline in Urinary Urgency as Assessed by VAS Change from Baseline at Day 42	-0.30 centimeters Standard Deviation 2.01	-0.84 centimeters Standard Deviation 2.74

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28 and 42

Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=43 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Voiding Frequency Change from Baseline at Day 7	-7.3 Voids Standard Deviation 12.6	-1.1 Voids Standard Deviation 20.3
Change From Baseline in Voiding Frequency Change from Baseline at Day 14	-8.8 Voids Standard Deviation 13.2	-5.8 Voids Standard Deviation 13.1
Change From Baseline in Voiding Frequency Change from Baseline at Day 28	-9.3 Voids Standard Deviation 15.9	-8.4 Voids Standard Deviation 12.8
Change From Baseline in Voiding Frequency Change from Baseline at Day 42	-9.8 Voids Standard Deviation 15.3	-7.2 Voids Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28 and 42

Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=43 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score Change from Baseline at Day 7	-2.39 score on a scale Standard Deviation 3.18	-2.00 score on a scale Standard Deviation 3.56
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score Change from Baseline at Day 14	-2.02 score on a scale Standard Deviation 3.90	-1.97 score on a scale Standard Deviation 3.82
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score Change from Baseline at Day 28	-2.93 score on a scale Standard Deviation 3.83	-2.87 score on a scale Standard Deviation 3.68
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score Change from Baseline at Day 42	-2.83 score on a scale Standard Deviation 4.11	-2.32 score on a scale Standard Deviation 3.64

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28 and 42

Population: Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=43 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=40 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score Change from Baseline at Day 7	-2.24 score on a scale Standard Deviation 2.74	-1.54 score on a scale Standard Deviation 2.97
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score Change from Baseline at Day 14	-2.33 score on a scale Standard Deviation 2.92	-1.62 score on a scale Standard Deviation 3.21
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score Change from Baseline at Day 28	-2.98 score on a scale Standard Deviation 3.14	-2.23 score on a scale Standard Deviation 3.26
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score Change from Baseline at Day 42	-2.48 score on a scale Standard Deviation 3.09	-1.58 score on a scale Standard Deviation 3.01

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.

Outcome measures

Measure	LiRIS® 400 Mg-Randomized Study n=46 Participants LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo-Randomized Study n=46 Participants LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Stricture:Improvement	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Stricture:No Change	100 percentage of participants	100 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Hunner's Lesions:Worsening	2 percentage of participants	2 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Hunner's Lesions:No Change	96 percentage of participants	89 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Stricture:Worsening	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Bladder Mucosal Erythema:Improvement	35 percentage of participants	15 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Bladder Mucosal Erythema:Worsening	13 percentage of participants	11 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Bladder Mucosal Erythema:No Change	50 percentage of participants	70 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Bladder Mucosal Erythema:Not Done	2 percentage of participants	4 percentage of participants
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings Hunner's Lesions:Improvement	2 percentage of participants	9 percentage of participants

Adverse Events

LiRIS® 400 mg - Randomized Study

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

LiRIS® Placebo - Randomized Study

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Sham Cystoscopic Procedure - Randomized Study

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

LiRIS 400 mg - Open Label Extension

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	LiRIS® 400 mg - Randomized Study n=46 participants at risk LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo - Randomized Study n=46 participants at risk LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	Sham Cystoscopic Procedure - Randomized Study n=11 participants at risk Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.	LiRIS 400 mg - Open Label Extension n=56 participants at risk LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open lable extension.
General disorders Chest Pain	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Cystitis Interstitial	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.

Other adverse events

Measure	LiRIS® 400 mg - Randomized Study n=46 participants at risk LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	LiRIS® Placebo - Randomized Study n=46 participants at risk LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	Sham Cystoscopic Procedure - Randomized Study n=11 participants at risk Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.	LiRIS 400 mg - Open Label Extension n=56 participants at risk LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open lable extension.
Renal and urinary disorders Dysuria	23.9% 11/46 • Number of events 13 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	15.2% 7/46 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	16.1% 9/56 • Number of events 12 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Bladder Pain	17.4% 8/46 • Number of events 9 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	23.9% 11/46 • Number of events 12 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	16.1% 9/56 • Number of events 10 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Bladder Discomfort	10.9% 5/46 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	4.3% 2/46 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Hematuria	15.2% 7/46 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	4.3% 2/46 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	10.7% 6/56 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Urethral Pain	8.7% 4/46 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	7.1% 4/56 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Urinary Tract Infection	8.7% 4/46 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	4.3% 2/46 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	12.5% 7/56 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Micturition Urgency	6.5% 3/46 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	8.7% 4/46 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Bladder Irritation	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Gastrointestinal disorders Diarrhea	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	3.6% 2/56 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
General disorders Headache	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	3.6% 2/56 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Pollakiuria	4.3% 2/46 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	5.4% 3/56 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Gastrointestinal disorders Abdominal Pain (Lower)	4.3% 2/46 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Gastrointestinal disorders Abdominal Pain	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	18.2% 2/11 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Urine Odor Abnormal	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Renal and urinary disorders Urine Abnormality	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Gastrointestinal disorders Nausea	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	3.6% 2/56 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Gastrointestinal disorders Vomiting	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	6.5% 3/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	5.4% 3/56 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Infections and infestations Fungal Infection	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	5.4% 3/56 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Infections and infestations Bacterial Infection	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Infections and infestations Papilloma Viral Infection	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	4.3% 2/46 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Nervous system disorders Hypoesthesia	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
General disorders Edema Peripheral	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	2.2% 1/46 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	3.6% 2/56 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
General disorders Fatigue	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
General disorders Pain	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	1.8% 1/56 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
General disorders Tenderness	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Metabolism and nutrition disorders Blood Triglycerides Increased	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/46 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	9.1% 1/11 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/56 • Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks] The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER