Trial Outcomes & Findings for Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease (NCT NCT00660673)

NCT ID: NCT00660673

Last Updated: 2022-12-02

Results Overview

Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that: * Resulted in death * Was life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect The severity of all AEs was characterized as mild, moderate or severe according to the following definitions: * Mild: usually transient and do not interfere with daily activities. * Moderate: low level of inconvenience or concern to the subject, may interfere with daily activities. * Severe: events interrupt the subject's usual daily activity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 262 participants
• Primary outcome timeframe: From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).
• Results posted on: 2022-12-02

Participant Flow

Enrollment began in November 2009 and was completed in October 2012. Participants were enrolled at 61 sites in 11 countries: Australia, Canada, Czech Republic, Israel, New Zealand, Poland, Portugal, the Russian Federation, Thailand, the United Kingdom, and the United States.

This study was an open-label extension study for participants with Parkinson's disease (PD) who had completed one of the prior studies S187.3.003 (NCT00360568) or S187.3.004 (NCT00335153). Participants were to receive continued access to levodopa-carbidopa intestinal gel (LCIG) in the extension study until treatment became commercially available in their home country.

Participant milestones

Measure	Levodopa-Carbidopa Intestinal Gel Participants received levodopa-carbidopa intestinal gel (LCIG), continuously administered through a percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.
Overall Study STARTED	262
Overall Study COMPLETED	145
Overall Study NOT COMPLETED	117

Reasons for withdrawal

Measure	Levodopa-Carbidopa Intestinal Gel Participants received levodopa-carbidopa intestinal gel (LCIG), continuously administered through a percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.
Overall Study Adverse Event	84
Overall Study Lack of Efficacy	7
Overall Study Withdrawal by Subject	22
Overall Study Administrative	2
Overall Study Protocol Violation	2

Baseline Characteristics

Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

Baseline characteristics by cohort

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.
Age, Continuous	64.1 years STANDARD_DEVIATION 8.9 • n=5 Participants
Age, Customized < 65 years	133 Participants n=5 Participants
Age, Customized ≥ 65 years	129 Participants n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	162 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	255 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	21 Participants n=5 Participants
Race/Ethnicity, Customized Black of African Heritage or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	239 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Population: All participants who received LCIG in this extension study

Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure.

At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug.

Serious AEs included any untoward medical occurrence that:

• Resulted in death
• Was life-threatening
• Required inpatient hospitalization or prolongation of an existing hospitalization
• Resulted in persistent or significant disability/incapacity
• was a congenital anomaly/birth defect

The severity of all AEs was characterized as mild, moderate or severe according to the following definitions:

• Mild: usually transient and do not interfere with daily activities.
• Moderate: low level of inconvenience or concern to the subject, may interfere with daily activities.
• Severe: events interrupt the subject's usual daily activity.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Treatment-emergent Adverse Events TEAE leading to death	58 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events Any treatment-emergent adverse event (TEAE)	253 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events TEAE at least possibly related to study drug	219 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events Serious TEAE	159 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events Severe TEAE	152 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events TEAE leading to premature study discontinuaton	82 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study

Device complications include complications with the pump, intestinal tube, PEG-J or stoma.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Device Complications Any device complication	244 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Device Complications Device complication leading to tube replacement	183 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Device Complications Device complication with associated adverse event	177 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Device Complications Device complication with associated adverse event leading to tube replacement	43 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with available sleep attack data. The number of participants who experienced a sleep attack with a bad outcome or problem is based on the number of participants who reported sleep attacks.

Participants were asked whether they experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. If yes, participants were asked if they suffered any "bad" outcome or problem from the falling asleep event.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Sleep Attacks Baseline: One or more sleep attacks	6 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Sleep Attacks Baseline: One or more sleep attacks with a bad outcome	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Sleep Attacks Post-baseline: One or more sleep attacks	27 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Sleep Attacks Post-baseline: One or more sleep attacks with a bad outcome	3 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with available MIDI data.

To monitor for the development of intense impulsive behavior the Minnesota Impulsive Disorder Interview (MIDI) was administered. The MIDI is a semi-structured clinical interview assessing pathological gambling, trichotillomania, kleptomania, pyromania, intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Intense Impulsive Behavior Baseline: Pathological Gambling	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Baseline: Trichotillomania	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Baseline: Kleptomania	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Baseline: Pyromania	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Baseline: Intermittent Explosive Disorder	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Baseline: Compulsive Buying	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Baseline: Compulsive Sexual Behavior	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Pathological Gambling	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Trichotillomania	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Kleptomania	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Pyromania	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Intermittent Explosive Disorder	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Compulsive Buying	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Intense Impulsive Behavior Post-baseline: Compulsive Sexual Behavior	14 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Once per year during the study; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study

A comprehensive assessment for the presence of melanoma was performed at least once a year by a dermatologist.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants Who Developed Melanoma	2 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Population: ll participants who received LCIG in this extension study

Adverse events of special interest (AESIs) were identified using standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQ) or company MedDRA queries (CMQs). The AESI in the following categories were identified on the basis of review of the clinical program and postmarketing observations where the treatment system is commercially available.

• Procedure and device associated events
• Polyneuropathy, included preferred terms in either the peripheral neuropathy or GuillainBarre syndrome standardized MedDRA query (narrow search), such as polyneuropathy, decreased vibratory sense, peripheral neuropathy, peripheral sensory neuropathy, neuralgia, demyelinating polyneuropathy, and sensory disturbance
• Weight loss
• Cardiovascular fatalities
• Respiratory tract aspiration including aspiration pneumonia/pneumonitis.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) TE AESI related to procedure and device	162 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) TE AESI related to polyneuropathy	24 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) TE AESI related to weight loss	53 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) TE AESI related to cardiovascular fatalities	7 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) TE AESI related to aspiration	71 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with available C-SSRS data.

The Columbia-Suicide Severity Rating Scale (C-SSRS) was implemented with Protocol Amendment 3 (20 March 2012) in order to assess suicidal behavior and ideation.

Suicidal ideation includes the wish to be dead, nonspecific active suicidal thoughts, active ideation without intent to act, active ideation with some intent to act, and active ideation with specific plan or intent. Suicidal behavior includes actual attempts, interrupted attempts, aborted attempts, completed suicide, and preparatory acts or behaviors.

The number of participants with affirmative responses on the C-SSRS at any time during the treatment period is reported.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=210 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Any Suicidal Ideation or Behavior Any suicidal ideation or behavior	32 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Any Suicidal Ideation or Behavior Any suicidal ideation	30 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Any Suicidal Ideation or Behavior Any suicidal behavior	6 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Any Suicidal Ideation or Behavior Non-suicidal self-injurious behavior	1 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 6 months until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter.

A vital sign value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=255 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Potentially Clinically Significant Vital Sign Values Supine Systolic Blood Pressure ≥180 mmHg and > 40 mmHg increase from Baseline	6 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Supine Systolic Blood Pressure ≤ 90 mmHg and > 30 mmHg decrease from Baseline	13 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Standing Systolic Blood Pressure ≥ 180 mmHg and > 40 mmHg increase from Baseline	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Standing Systolic Blood Pressure ≤ 90 mmHg and > 30 mmHg decrease from Baseline	26 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Orthostatic Change in Systolic Blood Pressure Decrease of ≥ 30 mmHg	73 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Supine Diastolic Blood Pressure ≥ 105 mmHg and > 30 mmHg increase from Baseline	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Supine Diastolic Blood Pressure ≤ 50 mmHg and > 30 mmHg decrease from Baseline	6 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Standing Diastolic Blood Pressure ≥ 105 mmHg and > 30 mmHg increase from Baseline	7 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Standing Diastolic Blood Pressure ≤ 50 mmHg and > 30 mmHg decrease from Baseline	14 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Orthostatic Change in Diastolic Blood Pressure Decrease of ≥ 20 mmHg	45 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Supine Pulse ≥ 120 bpm and > 30 bpm increase from Baseline	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Supine pulse ≤ 50 bpm and > 30 bpm decrease from Baseline	3 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Standing pulse ≥ 120 bpm and > 30 bpm increase from Baseline	5 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Standing pulse ≤ 50 bpm and > 30 bpm decrease from Baseline	4 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Temperature ≥ 38.3℃ and ≥ 1.1℃ increase from Baseline	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Weight ≥ 7% increase from Baseline	36 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Vital Sign Values Weight ≥ 7% decrease from Baseline	140 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 6 months until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter.

A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=196 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Red blood cells (RBC) < 2.0 × 10^12 cells/L (Female); < 2.5 × 10^12 cells/L (Male)	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Haemoglobin < 90 g/L (Female); < 100 g/L (Male)	9 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Haematocrit < 30% (Female); < 34% (Male)	16 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values White blood cells (WBC) < 2.8 × 10^9 cells/L	3 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values WBC > 16.0 × 10^9 cells/L	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Absolute neutrophil count < 1.2 × 10^9 cells/L	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Lymphocytes > 80%	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Absolute lymphocyte count < 0.75 × 10^9 cells/L	14 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Eosinophils > 10%	4 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Monocytes > 30%	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Platelet count < 95 × 10^9 cells/L	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Platelet count > 700 × 10^9 cells/L	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values Mean corpuscular volume (MCV) < 60 fL	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Hematology Laboratory Values MCV > 120 fL	0 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and every 6 months until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter

A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding baseline value.

ULN = upper limit of normal

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=198 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Uric acid > 500 µmol/L (Female); > 590 µmol/L (Male)	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Blood urea nitrogen (BUN) > 10.8 mmol/L	11 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Cholesterol > 12.9 mmol/L	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Creatinine > 177 µmol/L	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Calcium < 1.75 mmol/L	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Calcium > 3.0 mmol/L	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Total bilirubin > 2 x ULN	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Aspartate aminotransferase (AST) > 3 x ULN	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Alanine aminotransferase (ALT) > 3 x ULN	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Gamma glutamyl-transferase (GGT) > 3 x ULN	5 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Lactate dehydrogenase (LDH) > 3 x ULN	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Alkaline phosphatase (ALP) > 400 U/L	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Creatine phosphokinase (CPK) > 3 x ULN	6 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Non-fasting glucose < 2.78 mmol/L	4 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values Non-fasting glucose > 16.0 mmol/L	1 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days.

Population: All participants who received LCIG in this extension study with at least one post-baseline measurement for each parameter.

Special tests for vitamin deficiencies (folic acid, vitamin B6, vitamin B12, methylmalonic acid [MMA], and homocysteine) were implemented with Protocol Amendment 2 (27 July 2011). The number of participants with vitamin levels outside of the normal range at any time post-baseline is reported for each vitamin tested.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=214 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Number of Participants With Vitamin Levels Outside of the Normal Range Vitamin B12 < 148 pmol/L	22 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Vitamin B12 > 775 pmol/L	46 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Methylmalonic acid > 0.4 µmol/L	65 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Homocysteine < 3.7 µmol/L	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Homocysteine > 13.9 µmol/L	198 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Vitamin B6 < 20 nmol/L	155 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Vitamin B6 > 125 nmol/L	108 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vitamin Levels Outside of the Normal Range Folic acid < 4.5 nmol/L	6 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years).

Population: Participants who received LCIG during each year in this extension study

Participants could use oral levodopa-carbidopa for scheduled or supplemental bedtime/overnight doses after the pump was disconnected for the night, or as rescue medication in case of acute deterioration caused by failure of the LCIG system such as tubes and/or the pump or the onset of an acute illness.

The initiation of additional concomitant PD medication was allowed at the discretion of the Investigator if medically indicated.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=262 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 n=230 Participants Participants who received LCIG during Year 2 of the extension study.	Year 3 n=196 Participants Participants who received LCIG during Year 3 of the extension study.	Year 4 n=146 Participants Participants who received LCIG during Year 4 of the extension study.	Year 5 n=96 Participants Participants who received LCIG during Year 5 of the extension study.	Year 6 n=59 Participants Participants who received LCIG during Year 6 of the extension study.	Year 7 n=44 Participants Participants who received LCIG during Year 7 of the extension study.	Year 8 n=38 Participants Participants who received LCIG during Year 8 of the extension study.	Year 9 n=27 Participants Participants who received LCIG during Year 9 of the extension study.	Year 10 n=22 Participants Participants who received LCIG during Year 10 of the extension study.	> Year 10 n=9 Participants Participants who received LCIG after Year 10 of the extension study.
Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year No concomitant PD medications (LCIG only)	126 Participants	107 Participants	96 Participants	74 Participants	52 Participants	38 Participants	33 Participants	28 Participants	21 Participants	17 Participants	8 Participants
Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year Concomitant oral levodopa/carbidopa	100 Participants	91 Participants	74 Participants	55 Participants	37 Participants	16 Participants	9 Participants	8 Participants	5 Participants	4 Participants	1 Participants
Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year Other concomitant PD medications	36 Participants	32 Participants	26 Participants	17 Participants	7 Participants	5 Participants	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The PD symptom diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia.

"Off" time was defined as time when medication had worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness.

PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit.

A negative change for "off" time indicates improvement. The PD diary assessment was implemented with Protocol amendment 4 (December 2013) for participants at United States (US) sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment Change from initial LCIG infusion	-3.97 hours Standard Deviation 2.86	—	—	—	—	—	—	—	—	—	—
Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment Change from Baseline	-0.19 hours Standard Deviation 2.19	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia.

"On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Non-troublesome dyskinesia does not interfere with function or cause meaningful discomfort.

"On" time without troublesome dyskinesia is the sum of "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement.

The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment Change from initial LCIG infusion	3.86 hours Standard Deviation 3.31	—	—	—	—	—	—	—	—	—	—
Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment Change from Baseline	-0.51 hours Standard Deviation 3.19	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia.

"On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Troublesome dyskinesia interferes with function or causes meaningful discomfort.

PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement.

The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment Change from initial LCIG infusion	0.12 hours Standard Deviation 3.03	—	—	—	—	—	—	—	—	—	—
Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment Change from Baseline	0.70 hours Standard Deviation 2.66	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections:

I) Mentation, Behavior, and Mood;

II) Activities of Daily Living;

III) Motor Examinations;

IV) Complications of Therapy sections (including dyskinesias).

The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability. A negative change from Baseline indicates improvement.

The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment Change from initial LCIG infusion	1.51 score on a scale Standard Deviation 2.83	—	—	—	—	—	—	—	—	—	—
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment Change from Baseline	1.46 score on a scale Standard Deviation 2.29	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections:

I) Mentation, Behavior, and Mood;

II) Activities of Daily Living;

III) Motor Examinations;

IV) Complications of Therapy sections (including dyskinesias).

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. A negative change from Baseline indicates improvement.

The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment Change from initial LCIG infusion	3.04 score on a scale Standard Deviation 7.76	—	—	—	—	—	—	—	—	—	—
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment Change from Baseline	6.11 score on a scale Standard Deviation 5.48	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections:

I) Mentation, Behavior, and Mood;

II) Activities of Daily Living;

III) Motor Examinations;

IV) Complications of Therapy sections (including dyskinesias).

UPDRS Part III consists of 14 questions. Questions 20 - 26 are multi-part questions in that they are evaluated separately for multiple body parts. Counting each of these assessments leads to a total of 27 answers for Part III. The UPDRS 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. A negative change from Baseline indicates improvement.

The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment Change from Baseline	9.18 score on a scale Standard Deviation 10.63	—	—	—	—	—	—	—	—	—	—
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment Change from initial LCIG infusion	4.51 score on a scale Standard Deviation 14.71	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections:

I) Mentation, Behavior, and Mood;

II) Activities of Daily Living;

III) Motor Examinations;

IV) Complications of Therapy sections (including dyskinesias).

The UPDRS 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 ranges from 0 - 176 with 176 representing the worst (total) disability, and 0 no disability. A negative change from Baseline indicates improvement.

The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment Change from initial LCIG infusion	9.12 score on a scale Standard Deviation 20.91	—	—	—	—	—	—	—	—	—	—
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment Change from Baseline	16.82 score on a scale Standard Deviation 15.01	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections:

I) Mentation, Behavior, and Mood;

II) Activities of Daily Living;

III) Motor Examinations;

IV) Complications of Therapy sections (including Dyskinesias).

The UPDRS Part IV Score is the sum of all answers to the 11 questions that comprise Part IV, 4 of which are measured on a 5-point scale (0 - 4) and 7 which are measured on a 2-point scale (0 - 1). The Part IV score ranges from 0 - 23 with higher scores associated with more disability. A negative change from Baseline indicates improvement.

The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment Change from initial LCIG infusion	-2.27 score on a scale Standard Deviation 3.70	—	—	—	—	—	—	—	—	—	—
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment Change from Baseline	0.77 score on a scale Standard Deviation 2.86	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections:

I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias); and

The UPDRS Part IV dyskinesia Score is the sum of Questions 32 (What proportion of the waking day are dyskinesias present?), 33 (How disabling are the dyskinesias? ), and 34 (How painful are the dyskinesias?) on UPDRS Part IV, each of which are measured on a 5-point scale (0-4). The Part IV dyskinesia score ranges from 0 - 12 and higher scores are associated with more disability. A negative change from Baseline indicates improvement.

The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=82 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment Change from initial LCIG infusion	-0.19 score on a scale Standard Deviation 2.55	—	—	—	—	—	—	—	—	—	—
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment Change from Baseline	0.55 score on a scale Standard Deviation 1.86	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Population: Participants who were enrolled in the United States and had at least 1 efficacy assessment in the current study

The PDQ-39 is a self-administered questionnaire that comprises 39 items addressing the following eight domains of health that patients consider to be adversely affected by the disease:

• Mobility (e.g., fear of falling when walking) - 10 questions
• Activities of daily living (e.g., difficulty cutting food) - 6 questions
• Emotional well-being (e.g., feelings of isolation) - 6 questions
• Stigma (e.g., social embarrassment) - 4 questions
• Social support - 3 questions
• Cognition - 4 questions
• Communication - 3 questions
• Bodily discomfort - 3 questions

Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. The PDQ-39 summary index (range 0-100) includes responses to all 39 items. A negative change indicates improvement.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel n=102 Participants Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.	Year 2 Participants who received LCIG during Year 2 of the extension study.	Year 3 Participants who received LCIG during Year 3 of the extension study.	Year 4 Participants who received LCIG during Year 4 of the extension study.	Year 5 Participants who received LCIG during Year 5 of the extension study.	Year 6 Participants who received LCIG during Year 6 of the extension study.	Year 7 Participants who received LCIG during Year 7 of the extension study.	Year 8 Participants who received LCIG during Year 8 of the extension study.	Year 9 Participants who received LCIG during Year 9 of the extension study.	Year 10 Participants who received LCIG during Year 10 of the extension study.	> Year 10 Participants who received LCIG after Year 10 of the extension study.
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Summary Index: Change from initial LCIG infusion	-1.46 score on a scale Standard Deviation 16.98	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Summary Index: Change from Baseline	6.83 score on a scale Standard Deviation 13.14	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Mobility Domain: Change from initial LCIG infusion	-2.08 score on a scale Standard Deviation 27.98	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Mobility Domain: Change from Baseline	12.01 score on a scale Standard Deviation 21.81	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Activities of Daily Living Domain: Change from initial LCIG infusion	-1.55 score on a scale Standard Deviation 28.40	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Activities of Daily Living Domain: Change from Baseline	9.35 score on a scale Standard Deviation 20.40	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Emotional Well-Being Domain: Change from initial LCIG infusion	-0.58 score on a scale Standard Deviation 19.31	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Emotional Well-Being Domain: Change from Baseline	2.53 score on a scale Standard Deviation 16.95	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Stigma Domain: Change from initial LCIG infusion	-9.50 score on a scale Standard Deviation 22.49	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Stigma Domain: Change from Baseline	-0.18 score on a scale Standard Deviation 19.52	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Social Support Domain: Change from initial LCIG infusion	3.59 score on a scale Standard Deviation 19.54	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Social Support Domain: Change from Baseline	2.25 score on a scale Standard Deviation 17.88	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Cognition Domain: Change from initial LCIG infusion	1.78 score on a scale Standard Deviation 19.52	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Cognition Domain: Change from Baseline	6.56 score on a scale Standard Deviation 19.63	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Communication Domain: Change from initial LCIG infusion	3.19 score on a scale Standard Deviation 23.01	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Communication Domain: Change from Baseline	8.17 score on a scale Standard Deviation 19.27	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Bodily Discomfort Domain: Change from initial LCIG infusion	-4.74 score on a scale Standard Deviation 24.61	—	—	—	—	—	—	—	—	—	—
Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment Bodily Discomfort Domain: Change from Baseline	5.64 score on a scale Standard Deviation 19.70	—	—	—	—	—	—	—	—	—	—

Adverse Events

Levodopa-Carbidopa Intestinal Gel

Serious events: 159 serious events

Other events: 223 other events

Deaths: 59 deaths

Serious adverse events

Measure	Levodopa-Carbidopa Intestinal Gel n=262 participants at risk Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.
Blood and lymphatic system disorders ANAEMIA	1.9% 5/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Blood and lymphatic system disorders HAEMORRHAGIC ANAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders ANGINA PECTORIS	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders ATRIAL FIBRILLATION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIAC ARREST	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIAC FAILURE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIAC FAILURE ACUTE	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIAC FAILURE CHRONIC	0.38% 1/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.38% 1/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders CARDIOPULMONARY FAILURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders EXTRASYSTOLES	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders MYOCARDIAL INFARCTION	1.5% 4/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders SICK SINUS SYNDROME	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Cardiac disorders VENTRICULAR TACHYCARDIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Eye disorders CATARACT	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Eye disorders VENOUS STASIS RETINOPATHY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders ABDOMINAL PAIN	1.9% 5/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders BEZOAR	1.5% 4/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders CONSTIPATION	1.1% 3/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders DIARRHOEA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders DUODENAL ULCER	1.5% 4/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders DYSPHAGIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders GASTRIC ULCER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders GIANT CELL EPULIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders ILEUS PARALYTIC	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders INGUINAL HERNIA	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders INTESTINAL DILATATION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders INTESTINAL OBSTRUCTION	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders INTUSSUSCEPTION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders JEJUNAL ULCER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders MELAENA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders OBSTRUCTION GASTRIC	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders OESOPHAGEAL FOOD IMPACTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders OESOPHAGEAL ULCER HAEMORRHAGE	0.38% 1/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders OESOPHAGITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders PANCREATITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders PANCREATITIS ACUTE	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders PERITONITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders PNEUMOPERITONEUM	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders RECTAL PROLAPSE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders VOLVULUS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders VOMITING	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders ASTHENIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders CHEST PAIN	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders COMPLICATION OF DEVICE INSERTION	5.3% 14/262 • Number of events 24 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders DEATH	5.0% 13/262 • Number of events 13 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders DEVICE BREAKAGE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders DEVICE DISLOCATION	2.3% 6/262 • Number of events 8 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders DEVICE MATERIAL ISSUE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders DEVICE OCCLUSION	0.38% 1/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders MALAISE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders MEDICAL DEVICE SITE REACTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders MULTI-ORGAN FAILURE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders NECROSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders NON-CARDIAC CHEST PAIN	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders PYREXIA	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders SUDDEN DEATH	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Hepatobiliary disorders BILE DUCT STONE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Hepatobiliary disorders CHOLANGITIS SCLEROSING	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations ABDOMINAL ABSCESS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations ABSCESS LIMB	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations APPENDICITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations BRONCHITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations BRONCHOPNEUMONIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations CATHETER SITE INFECTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations CELLULITIS	0.76% 2/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations CORONA VIRUS INFECTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations DEVICE RELATED INFECTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations GANGRENE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations LOBAR PNEUMONIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations OSTEOMYELITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations PELVIC ABSCESS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations PNEUMONIA	7.6% 20/262 • Number of events 23 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations POST PROCEDURAL SEPSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations POSTOPERATIVE WOUND INFECTION	3.4% 9/262 • Number of events 11 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations PYELONEPHRITIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations PYELONEPHRITIS ACUTE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations PYOTHORAX	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations RESPIRATORY TRACT INFECTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations SEPSIS	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations SEPTIC SHOCK	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations URINARY TRACT INFECTION	1.9% 5/262 • Number of events 6 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations WOUND INFECTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations WOUND INFECTION PSEUDOMONAS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations WOUND INFECTION STAPHYLOCOCCAL	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications CONCUSSION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications CONTUSION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications EXTRADURAL HAEMATOMA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.38% 1/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications FALL	5.0% 13/262 • Number of events 15 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications FEMUR FRACTURE	1.5% 4/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications HEAD INJURY	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications HEAT STROKE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications HIP FRACTURE	1.9% 5/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications JOINT INJURY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications MEDICATION ERROR	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PERIPROSTHETIC FRACTURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PERIPROSTHETIC OSTEOLYSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications POST-TRAUMATIC PAIN	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PROCEDURAL SITE REACTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PUBIS FRACTURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications RIB FRACTURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications TIBIA FRACTURE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations BLOOD MAGNESIUM DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations BLOOD POTASSIUM DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations HAEMATOCRIT DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations HAEMOGLOBIN DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations HEART RATE DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations OXYGEN SATURATION DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations PLATELET COUNT DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations URINE OUTPUT DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations WEIGHT DECREASED	3.1% 8/262 • Number of events 10 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders CACHEXIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders DEHYDRATION	1.5% 4/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders HYPOKALAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders HYPONATRAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders MALNUTRITION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders VITAMIN B6 DEFICIENCY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders BACK PAIN	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders BONE PAIN	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders CAMPTOCORMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders MOBILITY DECREASED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.9% 5/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders OSTEOCHONDROSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders SCOLIOSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE LEUKAEMIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.76% 2/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders BALANCE DISORDER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders CEREBRAL HAEMORRHAGE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders CEREBRAL ISCHAEMIA	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.76% 2/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders COGNITIVE DISORDER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders CONVULSION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders DEMENTIA	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders EPILEPSY	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders ISCHAEMIC STROKE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders LOSS OF CONSCIOUSNESS	1.1% 3/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders MENTAL IMPAIRMENT	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders MONOPLEGIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders MYOCLONUS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders NEUROPATHY PERIPHERAL	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders ON AND OFF PHENOMENON	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders PARKINSON'S DISEASE	3.1% 8/262 • Number of events 8 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders PARKINSONIAN CRISIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders POLYNEUROPATHY	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders RUPTURED CEREBRAL ANEURYSM	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders SCIATICA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders SEDATION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders SYNCOPE	1.5% 4/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders ABNORMAL BEHAVIOUR	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders AFFECTIVE DISORDER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders AGGRESSION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders ANXIETY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders CONFUSIONAL STATE	0.76% 2/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders DELIRIUM	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders DOPAMINE DYSREGULATION SYNDROME	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders HALLUCINATION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders MENTAL STATUS CHANGES	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders PARANOIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders PSYCHOTIC DISORDER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders SLEEP ATTACKS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders SUICIDAL IDEATION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders SUICIDE ATTEMPT	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Renal and urinary disorders BLADDER NECK OBSTRUCTION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Renal and urinary disorders HAEMATURIA	0.38% 1/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Renal and urinary disorders NEPHROLITHIASIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Renal and urinary disorders RENAL FAILURE ACUTE	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Renal and urinary disorders STRESS URINARY INCONTINENCE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Renal and urinary disorders URINARY RETENTION	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Reproductive system and breast disorders PELVIC HAEMATOMA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Reproductive system and breast disorders PROSTATOMEGALY	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders BRONCHITIS CHRONIC	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders CHOKING	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.76% 2/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders PLEURAL DISORDER	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.5% 4/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	3.4% 9/262 • Number of events 12 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	1.5% 4/262 • Number of events 4 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders RESPIRATORY ACIDOSIS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	1.9% 5/262 • Number of events 5 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Skin and subcutaneous tissue disorders DECUBITUS ULCER	1.1% 3/262 • Number of events 3 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders CIRCULATORY COLLAPSE	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders DEEP VEIN THROMBOSIS	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders HYPOTENSION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders HYPOVOLAEMIC SHOCK	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders ORTHOSTATIC HYPOTENSION	0.76% 2/262 • Number of events 2 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders SHOCK HAEMORRHAGIC	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders SUBGALEAL HAEMATOMA	0.38% 1/262 • Number of events 1 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).

Other adverse events

Measure	Levodopa-Carbidopa Intestinal Gel n=262 participants at risk Participants received LCIG continuously administered through a PEG-J directly into the jejunum via a portable pump during 16 hours of wakefulness. Initial dosing was based on the dosing regimen that the participant received during the previous LCIG study. Dosing was individually optimized and adjusted as clinically indicated. In addition to a morning dose (to prime the intestinal tube and rapidly achieve the therapeutic dose level) of 5 to 10 mL (100 to 200 mg levodopa), and the continuous infusion usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour), participants were allowed to self-administer additional doses of LCIG to address immediate subjective needs (eg, deterioration of motor function). Participants received LCIG until it became commercially available.
Blood and lymphatic system disorders ANAEMIA	6.9% 18/262 • Number of events 21 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Eye disorders CATARACT	5.0% 13/262 • Number of events 17 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders ABDOMINAL PAIN	8.4% 22/262 • Number of events 27 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders CONSTIPATION	11.5% 30/262 • Number of events 39 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders DIARRHOEA	9.2% 24/262 • Number of events 29 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Gastrointestinal disorders NAUSEA	12.2% 32/262 • Number of events 40 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders COMPLICATION OF DEVICE INSERTION	7.3% 19/262 • Number of events 25 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
General disorders FATIGUE	5.7% 15/262 • Number of events 17 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations POSTOPERATIVE WOUND INFECTION	21.0% 55/262 • Number of events 95 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Infections and infestations URINARY TRACT INFECTION	17.2% 45/262 • Number of events 86 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications FALL	17.9% 47/262 • Number of events 70 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	14.5% 38/262 • Number of events 46 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications POST PROCEDURAL DISCHARGE	9.2% 24/262 • Number of events 31 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PROCEDURAL PAIN	10.7% 28/262 • Number of events 39 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Injury, poisoning and procedural complications PROCEDURAL SITE REACTION	12.6% 33/262 • Number of events 47 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations BLOOD HOMOCYSTEINE INCREASED	22.5% 59/262 • Number of events 64 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations VITAMIN B6 DECREASED	27.1% 71/262 • Number of events 98 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations VITAMIN B6 INCREASED	8.0% 21/262 • Number of events 25 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Investigations WEIGHT DECREASED	12.2% 32/262 • Number of events 36 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Metabolism and nutrition disorders VITAMIN B6 DEFICIENCY	7.6% 20/262 • Number of events 22 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders ARTHRALGIA	8.4% 22/262 • Number of events 31 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders BACK PAIN	8.0% 21/262 • Number of events 24 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.7% 15/262 • Number of events 20 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	6.5% 17/262 • Number of events 22 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders BALANCE DISORDER	5.3% 14/262 • Number of events 17 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders COGNITIVE DISORDER	6.9% 18/262 • Number of events 18 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders DYSKINESIA	10.7% 28/262 • Number of events 34 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Nervous system disorders PARKINSON'S DISEASE	10.7% 28/262 • Number of events 38 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders ANXIETY	9.2% 24/262 • Number of events 27 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders DEPRESSION	12.2% 32/262 • Number of events 35 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders HALLUCINATION	6.5% 17/262 • Number of events 20 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders INSOMNIA	11.8% 31/262 • Number of events 35 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Psychiatric disorders SLEEP ATTACKS	6.1% 16/262 • Number of events 19 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	15.6% 41/262 • Number of events 67 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).
Vascular disorders ORTHOSTATIC HYPOTENSION	5.7% 15/262 • Number of events 19 • From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, and maximum was 4217 days (11.5 years).

Additional Information

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