Trial Outcomes & Findings for Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects (NCT NCT00660387)

Last Updated: 2015-01-16

Results Overview

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

35 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2015-01-16

Participant Flow

Studies S187.3.001 (NCT00357994) and S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. All study information and results presented reflect the study data and analyses for the two studies combined.

Participant milestones

Participant milestones
Measure	LCIG + Placebo Capsules Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Study STARTED	37	34
Overall Study COMPLETED	35	31
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	LCIG + Placebo Capsules Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	0	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LCIG + Placebo Capsules n=37 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=34 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.	Total n=71 Participants Total of all reporting groups
Age, Customized >=65 years	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 9.5 • n=5 Participants	65.1 years STANDARD_DEVIATION 6.8 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.3 • n=5 Participants
Age, Customized <65 years	21 participants n=5 Participants	15 participants n=7 Participants	36 participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=35 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=31 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline to Week 12 in Average Daily Normalized "Off" Time	-4.04 hours Standard Error 0.65	-2.14 hours Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. "On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=35 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=31 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12	4.11 hours Standard Error 0.75	2.24 hours Standard Error 0.76

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12	-10.9 units on a scale Standard Error 3.3	-3.9 units on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12 CGI-S at Baseline	4.2 units on a scale Standard Deviation 0.7	4.6 units on a scale Standard Deviation 0.8
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12 CGI-I at Week 12	2.3 units on a scale Standard Deviation 1.2	3.2 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12	-1.8 units on a scale Standard Error 1.3	1.3 units on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in UPDRS Part III Score at Week 12	-1.5 units on a scale Standard Error 2.4	-2.9 units on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=32 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12	0.054 units on a scale Standard Error 0.043	-0.016 units on a scale Standard Error 0.043

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=23 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=23 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12	-2.8 units on a scale Standard Error 3.7	1.7 units on a scale Standard Error 3.3

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=35 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=31 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12	-0.11 units on a scale Standard Error 0.52	-0.03 units on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12	-17.3 units on a scale Standard Error 5.0	-6.8 units on a scale Standard Error 4.9

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12	-12.9 units on a scale Standard Error 5.3	-1.3 units on a scale Standard Error 5.2

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=35 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=32 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12	-7.1 units on a scale Standard Error 4.0	-4.9 units on a scale Standard Error 4.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12	-8.9 units on a scale Standard Error 4.4	-4.5 units on a scale Standard Error 4.4

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=32 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12	-3.9 units on a scale Standard Error 3.5	-0.1 units on a scale Standard Error 3.6

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12	-7.3 units on a scale Standard Error 4.0	-3.2 units on a scale Standard Error 3.9

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12	-9.5 units on a scale Standard Error 4.1	4.4 units on a scale Standard Error 4.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12	-13.5 units on a scale Standard Error 6.1	-10.2 units on a scale Standard Error 6.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12	-0.2 units on a scale Standard Error 0.4	-0.5 units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12	-1.1 units on a scale Standard Error 0.7	0.1 units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV was totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12	0.4 units on a scale Standard Error 0.5	0.8 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=33 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12	-3.6 units on a scale Standard Error 3.4	-2.1 units on a scale Standard Error 3.4

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.

The EQ VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=36 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=32 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12	5.2 units on a scale Standard Error 4.3	-6.3 units on a scale Standard Error 4.3

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.

The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=35 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=31 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Employment Impairment (EMP) I Status at Baseline Paid Employment (PE)=Yes	10 participants	8 participants
Employment Impairment (EMP) I Status at Baseline PE=Yes, 100% of Past 4 Weeks	6 participants	3 participants
Employment Impairment (EMP) I Status at Baseline PE=Yes, 25% of Past 4 Weeks	1 participants	1 participants
Employment Impairment (EMP) I Status at Baseline PE=Yes, Other % of Past 4 Weeks	1 participants	1 participants
Employment Impairment (EMP) I Status at Baseline Someone Else Runs the Household (SRH)=Yes	24 participants	25 participants
Employment Impairment (EMP) I Status at Baseline SRH=Yes, 100% of Time per Week	15 participants	13 participants
Employment Impairment (EMP) I Status at Baseline SRH=Yes, 75% of Time per Week	3 participants	4 participants
Employment Impairment (EMP) I Status at Baseline SRH=Yes, 50% of Time per Week	3 participants	5 participants
Employment Impairment (EMP) I Status at Baseline SRH=No	11 participants	6 participants
Employment Impairment (EMP) I Status at Baseline Are You Retired (R)=Yes	24 participants	23 participants
Employment Impairment (EMP) I Status at Baseline R=Yes, Premature Due to PD	13 participants	12 participants
Employment Impairment (EMP) I Status at Baseline PE=Yes, 75% of Past 4 Weeks	2 participants	1 participants
Employment Impairment (EMP) I Status at Baseline PE=Yes, 50% of Past 4 Weeks	0 participants	2 participants
Employment Impairment (EMP) I Status at Baseline PE=No	25 participants	23 participants
Employment Impairment (EMP) I Status at Baseline SRH=Yes, 25% of Time per Week	2 participants	1 participants
Employment Impairment (EMP) I Status at Baseline SRH=Yes, Other % of Time per Week	1 participants	2 participants
Employment Impairment (EMP) I Status at Baseline R=Yes, Old Age Pensioner	8 participants	8 participants
Employment Impairment (EMP) I Status at Baseline R=Yes, Premature Due to Other Condition	1 participants	1 participants
Employment Impairment (EMP) I Status at Baseline R=Yes, Other Reason	2 participants	2 participants
Employment Impairment (EMP) I Status at Baseline R=No	11 participants	8 participants

SECONDARY outcome

Timeframe: Week 12 (or early termination)

Population: Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.

Outcome measures

Outcome measures
Measure	LCIG + Placebo Capsules n=35 Participants Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=31 Participants Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Employment Impairment (EMP) II Status at Week 12 PE=Yes, 100% of Past 4 Weeks	6 participants	1 participants
Employment Impairment (EMP) II Status at Week 12 PE=Yes, 50% of Past 4 Weeks	1 participants	2 participants
Employment Impairment (EMP) II Status at Week 12 PE=Yes, Other % of Past 4 Weeks	2 participants	0 participants
Employment Impairment (EMP) II Status at Week 12 PE=No	25 participants	26 participants
Employment Impairment (EMP) II Status at Week 12 SRH=Yes, 75% of Time per Week	5 participants	4 participants
Employment Impairment (EMP) II Status at Week 12 SRH=Yes, 50% of Time per Week	0 participants	4 participants
Employment Impairment (EMP) II Status at Week 12 Paid Employment (PE)=Yes	10 participants	5 participants
Employment Impairment (EMP) II Status at Week 12 PE=Yes, 75% of Past 4 Weeks	1 participants	1 participants
Employment Impairment (EMP) II Status at Week 12 PE=Yes, 25% of Past 4 Weeks	0 participants	1 participants
Employment Impairment (EMP) II Status at Week 12 Someone Else Runs the Household (SRH)=Yes	22 participants	24 participants
Employment Impairment (EMP) II Status at Week 12 SRH=Yes, 100% of Time per Week	13 participants	12 participants
Employment Impairment (EMP) II Status at Week 12 SRH=Yes, 25% of Time per Week	2 participants	2 participants
Employment Impairment (EMP) II Status at Week 12 SRH=Yes, Other % of Time per Week	2 participants	2 participants
Employment Impairment (EMP) II Status at Week 12 SRH=No	13 participants	7 participants

Adverse Events

LCIG + Placebo Capsules

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo Gel + Levodopa-Carbidopa Capsules

Serious events: 7 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	LCIG + Placebo Capsules n=37 participants at risk Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=34 participants at risk Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Cardiac disorders ATRIAL FIBRILLATION	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Cardiac disorders ATRIAL FLUTTER	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PERITONITIS	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PNEUMOPERITONEUM	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders COMPLICATION OF DEVICE INSERTION	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations CATHETER SITE CELLULITIS	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations PNEUMONIA	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations BODY TEMPERATURE INCREASED	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SPINAL HAEMANGIOMA	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DYSKINESIA	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HYPERSOMNIA	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PARKINSON'S DISEASE	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders CONFUSIONAL STATE	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders DELUSION	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders HALLUCINATION	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders MUTISM	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders PSYCHOTIC DISORDER	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders RENAL CYST	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.

Other adverse events
Measure	LCIG + Placebo Capsules n=37 participants at risk Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.	Placebo Gel + Levodopa-Carbidopa Capsules n=34 participants at risk Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.8% 3/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL DISTENSION	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL PAIN	51.4% 19/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	29.4% 10/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders CONSTIPATION	21.6% 8/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	20.6% 7/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DIARRHOEA	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DYSPEPSIA	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders FLATULENCE	16.2% 6/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders GASTRITIS	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.8% 3/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders HIATUS HERNIA	8.1% 3/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders NAUSEA	29.7% 11/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	20.6% 7/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PNEUMOPERITONEUM	8.1% 3/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	2.9% 1/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders REFLUX OESOPHAGITIS	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders VOMITING	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders COMPLICATION OF DEVICE INSERTION	54.1% 20/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	41.2% 14/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders FATIGUE	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders OEDEMA PERIPHERAL	8.1% 3/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders PYREXIA	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations POSTOPERATIVE WOUND INFECTION	10.8% 4/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	23.5% 8/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	8.1% 3/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications FALL	10.8% 4/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	18.9% 7/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL DISCHARGE	10.8% 4/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.8% 3/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL PAIN	29.7% 11/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	35.3% 12/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL SITE REACTION	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations BACTERIAL TEST POSITIVE	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations VITAMIN B6 DECREASED	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations WEIGHT DECREASED	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations WHITE BLOOD CELLS URINE POSITIVE	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.8% 3/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	14.7% 5/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.4% 2/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DIZZINESS	8.1% 3/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DYSKINESIA	10.8% 4/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders FREEZING PHENOMENON	2.7% 1/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	5.9% 2/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HEADACHE	8.1% 3/37 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.8% 4/34 • From Screening to the end of study or early termination of treatment, including the removal of PEG-J (up to 12 weeks), plus 30 days. Serious adverse events (AEs) and treatment-emergent AEs are presented. Treatment-emergent adverse events were defined as AEs that began or worsened from date of the study device implantation to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.