Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications (NCT NCT01960842)

NCT ID: NCT01960842

Last Updated: 2018-05-30

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: 31 participants
• Primary outcome timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)
• Results posted on: 2018-05-30

Participant Flow

A total of 31 participants were enrolled and had undergone the N-J placement procedure and were included in the Safety Analysis Set; 1 participant did not have at least 1 post-PEG efficacy assessment and was excluded from the Full Analysis Set (FAS), which consisted of 30 participants.

Participant milestones

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Overall Study STARTED	31
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications

Baseline characteristics by cohort

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Age, Continuous	61.6 years STANDARD_DEVIATION 10.50 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Duration of Parkinson's Disease Since Initial Diagnosis	12.4 years STANDARD_DEVIATION 5.08 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the Full Analysis Set (FAS; all enrolled participants who received at least 1 dose of LCIG infusion during the PEG-J Period and had data for baseline and at least 1 post-PEG-J efficacy assessment) with available data.

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.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit Baseline	7.37 hours Standard Deviation 2.263
Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	2.72 hours Standard Deviation 2.320

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS with available data.

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. Positive change from baseline for "on" time indicates improvement.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit Baseline	7.52 hours Standard Deviation 2.505
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	13.10 hours Standard Deviation 2.453

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS.

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

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit Baseline	35.5 units on a scale Standard Deviation 13.75
Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	23.5 units on a scale Standard Deviation 13.59

SECONDARY outcome

Timeframe: Final PEG-J Visit (up to week 12)

Population: All participants in the FAS with available data.

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

Measure

Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).

Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit

1.9 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Final PEG-J Visit (up to week 12)

Population: All participants in the FAS with available data.

The PGI-C is a 7-point response scale. The subjects were to rate their change in status from Screening Visit 1 using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. The responses of "Minimally improved," "Much improved," and "Very much improved" on the PGI-C were used to define responders.

Outcome measures

Measure

Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).

Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit

2.0 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS.

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

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit Baseline	9.4 units on a scale Standard Deviation 6.63
Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	7.6 units on a scale Standard Deviation 6.93

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS.

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

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit Baseline	16.5 units on a scale Standard Deviation 9.70
Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit Final PEG-J visit	14.3 units on a scale Standard Deviation 11.30

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS with available data.

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. Positive change from baseline for "on" time indicates improvement.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit Baseline	1.12 hours Standard Deviation 2.311
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	0.12 hours Standard Deviation 0.394

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS.

The PDQ-39 is a self-administered questionnaire which comprises 39 items (each question answered on a 5-point scale) addressing 8 domains of health in Parkinson's disease patients: Mobility (e.g., fear of falling when walking) includes 10 questions; Emotional Well-being (e.g., feelings of isolation) includes 6 questions; Stigma (e.g., social embarrassment) includes 4 questions; Social Support includes 3 questions; Cognition includes 4 questions; Communication includes 3 questions; and Bodily Discomfort includes 3 questions. 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

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Mobility Domain-Baseline	55.7 units on a scale Standard Deviation 19.46
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Mobility Domain-Last PEG-J visit	36.5 units on a scale Standard Deviation 22.49
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Emotional Well-Being Domain-Baseline	30.8 units on a scale Standard Deviation 19.13
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Emotional Well-Being Domain-Last PEG-J visit	24.3 units on a scale Standard Deviation 18.02
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Stigma Domain-Baseline	20.6 units on a scale Standard Deviation 22.21
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Stigma Domain-Last PEG-J visit	13.1 units on a scale Standard Deviation 20.78
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Social Support Domain-Baseline	16.1 units on a scale Standard Deviation 18.69
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Social Support Domain-Last PEG-J visit	14.6 units on a scale Standard Deviation 21.35
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Cognition Domain-Baseline	28.5 units on a scale Standard Deviation 19.26
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Cognition Domain-Last PEG-J visit	14.6 units on a scale Standard Deviation 13.16
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Communication Domain-Baseline	13.3 units on a scale Standard Deviation 14.62
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Communication Domain-Last PEG-J visit	14.4 units on a scale Standard Deviation 16.94
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Bodily Discomfort Domain-Baseline	35.0 units on a scale Standard Deviation 21.60
Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit Bodily Discomfort Domain-Last PEG-J visit	17.2 units on a scale Standard Deviation 14.83

SECONDARY outcome

Timeframe: Baseline and Final PEG-J Visit (up to Week 12)

Population: All participants in the FAS.

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 to176, with 176 representing the worst (total) disability, and 0 representing no disability.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit Baseline	27.7 units on a scale Standard Deviation 15.53
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	22.9 units on a scale Standard Deviation 17.53

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS.

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 to 16 and higher scores are associated with more disability.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit Baseline	1.8 units on a scale Standard Deviation 2.02
Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	0.9 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS.

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 to 23 and higher scores are associated with more disability.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=30 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit Baseline	8.7 units on a scale Standard Deviation 3.15
Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	5.5 units on a scale Standard Deviation 3.08

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS with available data.

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.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=28 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Average Daily Normalized "Off" Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit Baseline	7.32 hours Standard Deviation 2.290
Average Daily Normalized "Off" Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	2.67 hours Standard Deviation 2.341

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)

Population: All participants in the FAS with available data.

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.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Average Daily Normalized "Off" Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit Baseline	7.37 hours Standard Deviation 2.263
Average Daily Normalized "Off" Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit Last PEG-J visit	2.78 hours Standard Deviation 2.382

SECONDARY outcome

Timeframe: Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12

Population: All participants in the FAS with available data.

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. n= the number of participants with available data at each time point.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=29 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Baseline (n=29)	7.37 hours Standard Deviation 2.263
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Week 2 (n=29)	3.17 hours Standard Deviation 2.365
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Week 4 (n=29)	3.68 hours Standard Deviation 3.077
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Week 6 (n=29)	2.61 hours Standard Deviation 2.318
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Week 8 (n=27)	2.77 hours Standard Deviation 2.324
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Week 10 (n=27)	2.47 hours Standard Deviation 2.210
Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit Week 12 (n=27)	2.45 hours Standard Deviation 2.094

SECONDARY outcome

Timeframe: From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.

Population: Safety Analysis Set: All subjects who had undergone the N-J placement procedure.

An adverse event (AE) is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs (TEAEs) are defined as any event that began or worsened in severity after N-J placement. The investigator assessed the relationship of each event to the use of study drug as Reasonable Possibility or No Reasonable Possibility.

For more details on adverse events please see the AE section below.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE at least possibly related to LCIG System	30 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any severe TEAE	2 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any SAE	4 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE Leading to Discontinuation of Study	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Death	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Death related to AE	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE	31 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE at least possibly related to LCIG	0 participants

SECONDARY outcome

Timeframe: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)

Population: Safety analysis set.

Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), body temperature (Temp), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuSBP <=90 and >30 mm Hg ↓ from BL	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuSBP >=180 and >40 mm Hg ↑ from BL	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StSBP <=90 and >30 mm Hg ↓ from BL	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StSBP >=180 and >40 mm Hg ↑ from BL	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters OSBP: ↓ >=30 mm Hg Supine to Standing	8 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuDBP <=50 and >30 mm Hg ↓ from BL	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuDBP >=105 and >30 mm Hg ↑ from BL	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StDBP <=50 and >30 mm Hg ↓ from BL	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StDBP >=105 and >30 mm Hg ↑ from BL	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters ODBP: ↓ >=20 mm Hg Supine to Standing	11 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuP <=50 and >30 bpm ↓ from BL	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuP >=120 and >30 bpm ↑ from BL	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StP <=50 and >30 bpm ↓ from BL	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StP >=120 and >30 bpm ↑ from BL	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Weight <=7% ↓ from BL	8 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Weight >=7% ↑ from BL	2 participants

SECONDARY outcome

Timeframe: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)

Population: Safety analysis set.

Terms abbreviated in the table include females (f), males (m), and femtoliters (fL).

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Haemoglobin <90 g/L (f); <100 g/L (m)	1 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Haematocrit <30% (f); <34% (m)	2 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Red Blood Cells <2.0 10^12/L (f); <2.5 10^12/L (m)	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Platelet Count <95 10^9/L	1 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Platelet Count >700 10^9/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters White Blood Cells <2.8 10^9/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters White Blood Cells >16.0 10^9/L	1 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Lymphocytes >80%	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Monocytes >30%	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Eosinophils >10%	1 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Mean Corpuscular Volume <60 fL	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Mean Corpuscular Volume >120 fL	0 participants

SECONDARY outcome

Timeframe: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)

Population: Safety analysis set.

Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Alanine Aminotransferase >3xULN	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Aspartate Aminotransferase >3xULN	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Gamma-glutamyl Transferase >3x ULN	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Alkaline Phosphatase >400 U/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Total Bilirubin >2xULN	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Creatine Phosphokinase >3x ULN	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Creatinine >177 µmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Blood Urea Nitrogen >10.8 mmol/L	2 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Uric Acid>500µmol/L(f);>590µmol/L(m)	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Calcium <1.75 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Calcium >3.0 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Sodium <126 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Sodium >156 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Potassium <3.0 mmol/L	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Potassium >6.0 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Non-fasting Glucose <2.78 mmol/L	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Non-fasting Glucose >16.0 mmol/L	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Albumin <25 g/L	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Albumin >70 g/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Total Protein <45 g/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Cholesterol >12.9 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Triglycerides >5.6 mmol/L	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Lactate dehydrogenase >3x ULN	0 participants

SECONDARY outcome

Timeframe: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)

Population: Safety analysis set.

Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), QT interval corrected for heart rate using Fridericia's formula (QTcF), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively. n = the number of participants with available data at each time point.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 Participants All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) HR <=50 and >30 bpm ↓ from BL (n=31)	0 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) HR >=120 and >30 bpm ↑ from BL (n=31)	0 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) PR Interval <120 msec (n=30)	0 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) PR Interval >220 msec (n=30)	1 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) QTcB Interval >480 msec (n=31)	1 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) QTcB Interval >60 msec ↑ from BL (n=31)	1 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) QTcF Interval >480 msec (n=31)	0 participants
Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) QTcF Interval >60 msec ↑ from BL (n=31)	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)

Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for neurological examination findings was not performed per protocol.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)

Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for physical examination findings was not performed per protocol.

Outcome measures

Outcome data not reported

Adverse Events

Levodopa-Carbidopa Intestinal Gel (LCIG)

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 participants at risk All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders ABDOMINAL PAIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders CONSTIPATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders GASTROINTESTINAL PERFORATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders MELAENA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders DEVICE DISLOCATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders DEVICE KINK	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations SEPSIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications FEMUR FRACTURE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.

Other adverse events

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=31 participants at risk All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Blood and lymphatic system disorders ANAEMIA	9.7% 3/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Cardiac disorders CARDIAC VALVE DISEASE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Cardiac disorders PALPITATIONS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Eye disorders VITREOUS FLOATERS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders ABDOMINAL DISTENSION	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders ABDOMINAL PAIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders CONSTIPATION	19.4% 6/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders DENTAL CARIES	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders DIARRHOEA	19.4% 6/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders DRY MOUTH	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders GASTRIC ULCER	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders ILEUS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders NAUSEA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders PNEUMOPERITONEUM	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders STOMATITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Gastrointestinal disorders TOOTHACHE	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders CATHETER SITE PAIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders CATHETER SITE PRURITUS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders CHEST DISCOMFORT	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders CHEST PAIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders COMPLICATION OF DEVICE INSERTION	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
General disorders PYREXIA	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations ALVEOLAR OSTEITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations BODY TINEA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations CATHETER SITE INFECTION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations INCISION SITE CELLULITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations INCISION SITE INFECTION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations NASOPHARYNGITIS	19.4% 6/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations RHINITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations SIALOADENITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations STOMA SITE CELLULITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations STOMA SITE INFECTION	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Infections and infestations TINEA PEDIS	9.7% 3/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications CONTUSION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications FALL	19.4% 6/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications INCISION SITE DERMATITIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	12.9% 4/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications INCISION SITE PAIN	41.9% 13/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications INCISION SITE RASH	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications LACERATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications PROCEDURAL PAIN	16.1% 5/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications RIB FRACTURE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications SCRATCH	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications SKIN ABRASION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications STOMA SITE ERYTHEMA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications SUTURE RELATED COMPLICATION	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications TOOTH FRACTURE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Injury, poisoning and procedural complications WOUND COMPLICATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Investigations BLOOD GLUCOSE INCREASED	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Investigations BLOOD HOMOCYSTEINE INCREASED	16.1% 5/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Investigations BLOOD PRESSURE DECREASED	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Investigations BLOOD PRESSURE INCREASED	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Investigations BLOOD TRIGLYCERIDES INCREASED	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Investigations WEIGHT DECREASED	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Metabolism and nutrition disorders DECREASED APPETITE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Metabolism and nutrition disorders DIABETES MELLITUS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Metabolism and nutrition disorders HYPONATRAEMIA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Metabolism and nutrition disorders MALNUTRITION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders FOOT DEFORMITY	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders MYALGIA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Musculoskeletal and connective tissue disorders POSTURE ABNORMAL	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders CARPAL TUNNEL SYNDROME	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders CEREBRAL INFARCTION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders DYSKINESIA	16.1% 5/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders DYSTONIA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders HEADACHE	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders METABOLIC ENCEPHALOPATHY	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders MIGRAINE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders RADICULOPATHY	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Nervous system disorders RESTLESS LEGS SYNDROME	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Psychiatric disorders AGITATION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Psychiatric disorders ANXIETY	9.7% 3/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Psychiatric disorders HEAD BANGING	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Psychiatric disorders ILLUSION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Psychiatric disorders INSOMNIA	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Psychiatric disorders NIGHTMARE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Renal and urinary disorders DYSURIA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders ACNE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders DRY SKIN	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders ECZEMA	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	32.3% 10/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders PETECHIAE	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders PRURITUS	6.5% 2/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Skin and subcutaneous tissue disorders SKIN ULCER	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.
Vascular disorders HYPERTENSION	3.2% 1/31 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the N-J placement to 30 days after device removal or until the first dose of extension study drug for those who chose to continue LCIG treatment.

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