Efficacy and Safety of Carbidopa/Levodopa/Entacapone in P... | NCT00099268

Name	Class
Orion Corporation, Orion Pharma	INDUSTRY

Label	Type	Description	Intervention Names
Carbidopa/levodopa/entacapone	Experimental	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.	Drug: Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopa	Active Comparator	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.	Drug: Immediate release carbidopa/levodopa

Name	Type	Description	Arm Group Labels	Other Names
Carbidopa/levodopa/entacapone	Drug	Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.	Carbidopa/levodopa/entacapone

Measure	Description	Time Frame
Time to First Occurrence of Dyskinesia	Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.	Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first

Measure	Description	Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)	The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Mayo Clinic

PubMed Identifier	Type	Citation	Retractions
20582993	Derived	Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060.

ID	Title	Description
FG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to First Occurrence of Dyskinesia

Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.

The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.

Posted

Number

95% Confidence Interval

weeks

Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first

ID	Title	Description
OG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
OG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Units	Counts
Participants	OG000373 OG001372

Title

Denominators

Categories

Title	Measurements
	OG00090.7± 47.9(65.3 to 104.0) OG001117.1± 51.5(92.1 to 132.6)

Secondary

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)

The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 6 and Week 130

ID	Title	Description
OG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
OG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Secondary

Occurrence of Wearing-off

Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.

Posted

Number

Participants

Baseline to Week 134

ID	Title	Description
OG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
OG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Secondary

Time to First Occurrence of Wearing-off

Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.

Posted

Mean

Standard Error

Weeks

Baseline to end of study (134-208 weeks of treatment)

ID	Title	Description
OG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
OG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Secondary

Occurrence of Dyskinesia

Posted

Number

Participants

Baseline to Week 208

ID	Title	Description
OG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
OG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Secondary

Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)

The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to Week 156

ID	Title	Description
OG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
OG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0015 affected371 at risk
Angina unstable	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0011 affected371 at risk
Atrial flutter	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Bradycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Cardiac arrest	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Cardiac flutter	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0012 affected371 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected373 at risk EG0010 affected371 at risk
Palpitations	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Muscular dystrophy	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Vitello-intestinal duct remnant	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Chalazion	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Eyelid ptosis	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected373 at risk EG0012 affected371 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0013 affected371 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Chest discomfort	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0011 affected371 at risk
Chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0012 affected371 at risk
General physical health deterioration	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Non-cardiac chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Orthostatic intolerance	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Acute sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Appendicitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Arthritis bacterial	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Bursitis infective	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Erysipelas	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Herpes zoster	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Lobar pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Postoperative wound infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Viral infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Accident at work	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Drug administration error	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0007 affected373 at risk EG0017 affected371 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0011 affected371 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0012 affected371 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Weight decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0013 affected371 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0013 affected371 at risk
Bursa calcification	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected373 at risk EG0015 affected371 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected373 at risk EG0012 affected371 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0006 affected373 at risk EG0015 affected371 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Cartilage neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0012 affected371 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0009 affected373 at risk EG0012 affected371 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0014 affected371 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Uterine leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Amnesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Balance disorder	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Coma	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Dystonia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Facial palsy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Loss of consciousness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Parkinson's disease	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0011 affected371 at risk
Parkinsonism	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0012 affected371 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Sciatica	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Spinal claudication	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Stupor	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Sudden onset of sleep	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Syncope	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Tremor	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Delirium	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Disorientation	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Hallucination	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Hypersexuality	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Mental status changes	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0012 affected371 at risk
Rapid eye movements sleep abnormal	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Stress	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Urinary fistula	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0010 affected371 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected373 at risk EG0013 affected371 at risk
Pharyngeal hypoaesthesia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Precancerous skin lesion	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Aortic aneurysm	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk
Circulatory collapse	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0012 affected371 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0012 affected371 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Phlebitis superficial	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0010 affected371 at risk
Thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected373 at risk EG0011 affected371 at risk
Varicose vein	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected373 at risk EG0011 affected371 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00050 affected373 at risk EG00144 affected371 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00065 affected373 at risk EG00128 affected371 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected373 at risk EG00113 affected371 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected373 at risk EG00120 affected371 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000114 affected373 at risk EG00170 affected371 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00022 affected373 at risk EG0019 affected371 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG00040 affected373 at risk EG00142 affected371 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG00027 affected373 at risk EG00134 affected371 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00020 affected373 at risk EG00120 affected371 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00034 affected373 at risk EG00143 affected371 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00019 affected373 at risk EG00117 affected371 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00020 affected373 at risk EG00124 affected371 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00028 affected373 at risk EG00136 affected371 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00038 affected373 at risk EG00143 affected371 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00047 affected373 at risk EG00153 affected371 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00020 affected373 at risk EG00121 affected371 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00037 affected373 at risk EG00132 affected371 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00059 affected373 at risk EG00146 affected371 at risk
Dyskinesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected373 at risk EG00110 affected371 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00037 affected373 at risk EG00126 affected371 at risk
Somnolence	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00037 affected373 at risk EG00128 affected371 at risk
Tremor	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected373 at risk EG00126 affected371 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00025 affected373 at risk EG00117 affected371 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00037 affected373 at risk EG00127 affected371 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00057 affected373 at risk EG00151 affected371 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00047 affected373 at risk EG00153 affected371 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected373 at risk EG00119 affected371 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected373 at risk EG00127 affected371 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected373 at risk EG00111 affected371 at risk

ID	Term
D010300	Parkinson Disease
D020820	Dyskinesias

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C481098	Stalevo
D007980	Levodopa
C009265	carbidopa, levodopa drug combination

ID	Term
D004295	Dihydroxyphenylalanine
D002395	Catecholamines
D000588	Amines
D009930	Organic Chemicals
D002396	Catechols
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010649	Phenylalanine
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D014443	Tyrosine

ID	Title	Description
BG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
BG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Carbidopa/Levodopa/Entacapone	Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.			91	373	310	373
EG001	Carbidopa/Levodopa	Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.			84	371	291	371