A 12-week Randomized Study to Evaluate Oral Istradefyllin... | NCT01968031

ID	Type	Description	Link
2013-002254-70	EudraCT Number

Status Module

Name	Class
Kyowa Hakko Kirin Pharma, Inc.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Istradefylline 20 mg/day	Experimental	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.	Drug: Istradefylline 20 mg Drug: Placebo
Istradefylline 40 mg/day	Experimental	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.	Drug: Istradefylline 40 mg Drug: Placebo
Placebo	Placebo Comparator	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Istradefylline 40 mg	Drug	Istradefylline 40 mg and placebo	Istradefylline 40 mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12	Based on the 24-hour ON/OFF patient diary data.	Baseline, Week 2, Week 6, Week 10 and Week 12.

Secondary Outcomes

Measure	Description	Time Frame
Total Hours of ON Time Per Day Without Troublesome Dyskinesia	Based on Patient's ON/OFF Diary	Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Kyowa Hakko Kirin Pharma, Inc.	Kyowa Hakko Kirin Pharma, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Kyowa PD Site		Phoenix	Arizona	85004	United States
Kyowa PD Site

References Module

Label	URL
Fox Trial Finder is a clinical trial matching tool that helps a Parkinson's patient connect with research sites. Volunteers who sign up will receive a list of trials in their area.	View source

ID	Title	Description
FG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
FG001	Istradefylline 20 mg/Day

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00063.8(41 to 86) BG00163.5(41 to 87) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00080 BG00176 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000199 BG001192 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00011 BG00111 BG002

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

Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12

Based on the 24-hour ON/OFF patient diary data.

The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week

Posted

Median

Full Range

hours

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo

Units	Counts
Participants	OG000198 OG001194 OG002200

Title

Denominators

Categories

Baseline

- ParticipantsOG000198
- ParticipantsOG001194
- ParticipantsOG002200

Title	Measurements

Secondary

Total Hours of ON Time Per Day Without Troublesome Dyskinesia

Based on Patient's ON/OFF Diary

The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week

Posted

Mean

Full Range

hours

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo

Secondary

Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);

The number of subjects in each row is based on the number of subjects with data for the corresponding week

Posted

Mean

Full Range

score on a scale

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day

Secondary

Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)

The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response.

The number of subjects in each row is based on the number of subjects with data for the corresponding week

Posted

Mean

Full Range

score on a scale

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo

Secondary

Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)

The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response.

The number of subjects in each row is based on the number of subjects with data for the corresponding week

Posted

Mean

Full Range

score on a scale

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day

Secondary

Total UPDRS (Parts I + II + III);

The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response.

The number of subjects in each row is based on the number of subjects with data for the corresponding week

Posted

Mean

Full Range

score on a scale

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo

Secondary

Patient Global Impression - Improvement (PGI-I) Scale

The "key symptom" on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale:

1 = Moderate improvement (or greater)
2 = Mild improvement
3 = No change from baseline
4 = Mild deterioration
5 = Moderate deterioration (or greater)

A lower number is a better outcome. Overall condition is presented below.

The number of subjects in each row is based on the number of subjects with data for the corresponding week

Posted

Count of Participants

Participants

Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002

Secondary

Sleep Time in Hours Per Day Based Upon 24-hour Diaries.

The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week

Posted

Mean

Full Range

hours

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo

Secondary

Percentage of Awake Time Per Day Spent in the OFF State

The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week

Posted

Mean

Full Range

percentage of hours

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo

Secondary

Percentage of ON Time Per Day Without Troublesome Dyskinesia.

The number of subjects in each row is based on the number of subjects with valid diary entries for the corresponding week

Posted

Mean

Full Range

percentage of hours

Baseline, Week 2, Week 6, Week 10 and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo

Secondary

Montreal Cognitive Assessment (MoCA)

The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows:

Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points

Scores can range from 0 to 30. A score of 26 or above is considered normal.

Intent-to-Treat Analysis set: Includes all subjects randomized to a treatment arm and with both a valid baseline and at least one valid post-baseline patient diary.

Posted

Mean

Full Range

score on a scale

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002	Istradefylline 40 mg/Day

Secondary

Beck Depression Inventory (BDI)

The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale:

0 = I do not feel sad
1 = I feel sad
2 = I am sad all the time and I can't snap out of it
3 = I am so sad or unhappy that I can't stand it

The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below:

0 to 9: minimal depression
10 to 18: mild depression
19 to 29: moderate depression
30 to 63: severe depression

The number of subjects in each row is based on the number of subjects with data for the corresponding week

Posted

Mean

Full Range

score on a scale

Baseline and Week 12.

ID	Title	Description
OG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
OG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
OG002

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo	0	204	7	204	111	204
EG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo	0	201	6	201	117	201
EG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo	1	207	8	207	132	207

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure acute	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Angina pectoris	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Oedema	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Fatigue	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Bacteraemia	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Wound infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Septic shock	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Sepsis syndrome	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Pneumonia	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Peritonitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events1 affected207 at risk
Infectious pleural effusion	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Anaesthetic complication neurological	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Medical observation	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Alanine aminotransferase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Parkinson's disease	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Delirium	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Confusional state	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0004 events3 affected204 at risk EG0012 events2 affected201 at risk EG0023 events3 affected207 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0022 events2 affected207 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Heart alternation	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Tachycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Bradycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Palpitations	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0022 events2 affected207 at risk
Presbyacusis	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Hypothyroidism	Endocrine disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Diplopia	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Myopia	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Dry eye	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Vision blurred	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0022 events2 affected207 at risk
Binocular eye movement disorder	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Vitreous detachment	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Conjunctivitis	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Vomiting	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0013 events3 affected201 at risk EG0026 events6 affected207 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0018 events8 affected201 at risk EG00213 events12 affected207 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Diverticulitis	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0005 events5 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0023 events3 affected207 at risk
Dental caries	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0008 events8 affected204 at risk EG0011 events1 affected201 at risk EG0025 events4 affected207 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0023 events3 affected207 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0013 events3 affected201 at risk EG0028 events8 affected207 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Anal spasm	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Flatulence	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Irritability	General disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Influenza like illness	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Fatigue	General disorders	MedDRA (16.1)	Systematic Assessment	EG0006 events6 affected204 at risk EG0013 events3 affected201 at risk EG0028 events8 affected207 at risk
Energy increased	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Asthenia	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0022 events2 affected207 at risk
Chest discomfort	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
General physical health deterioration	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Therapeutic response decreased	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Pyrexia	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Suprapubic pain	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Pain	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Oedema peripheral	General disorders	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Oedema	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Non-cardiac chest pain	General disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Malaise	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Gait disturbance	General disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0024 events4 affected207 at risk
Vessel puncture site bruise	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Local swelling	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events1 affected207 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Viral infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Urinary tract infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0007 events6 affected204 at risk EG0016 events6 affected201 at risk EG0028 events7 affected207 at risk
Tooth abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Tinea pedis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Sinusitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0023 events3 affected207 at risk
Rhinitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Nasopharyngitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG00110 events8 affected201 at risk EG0022 events2 affected207 at risk
Nail infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Lyme disease	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Laryngitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Influenza	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0014 events4 affected201 at risk EG0024 events4 affected207 at risk
Croup infectious	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Abscess limb	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Acute sinusitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0006 events6 affected204 at risk EG0012 events2 affected201 at risk EG0023 events3 affected207 at risk
Cellulitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Bronchitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Cystitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0022 events2 affected207 at risk
Ear infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Herpes zoster	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Respiratory tract infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0023 events3 affected207 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Periorbital contusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Musculoskeletal injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0024 events2 affected207 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG00012 events9 affected204 at risk EG00117 events13 affected201 at risk EG00222 events18 affected207 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0014 events4 affected201 at risk EG0025 events4 affected207 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0015 events5 affected201 at risk EG0025 events3 affected207 at risk
Blood calcium increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Blood calcium decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0022 events1 affected207 at risk
Alanine aminotransferase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Biopsy skin	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Blood bilirubin increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Amylase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0004 events4 affected204 at risk EG0012 events2 affected201 at risk EG0023 events2 affected207 at risk
White blood cells urine positive	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
White blood cell count decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0002 events1 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Weight increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Weight decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Urine transitional cells present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Urine ketone body present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Urinary casts	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
White blood cell count increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Specific gravity urine increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Red blood cell count decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
QRS axis abnormal	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Protein urine present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Precancerous cells present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Occult blood	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Neutrophil count increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Monocyte count increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Nitrite urine present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Lymphocyte percentage decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Lymphocyte count decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0022 events1 affected207 at risk
Lipase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0005 events5 affected204 at risk EG0012 events2 affected201 at risk EG0023 events2 affected207 at risk
Hepatic enzyme increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Heart rate increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Haemoglobin decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Haematocrit decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Red blood cells urine positive	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Eosinophil percentage increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Eosinophil count increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Electrocardiogram abnormal	Investigations	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Crystal urine present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0022 events1 affected207 at risk
Cardiac murmur	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Blood urea increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Blood triglycerides increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Blood pressure increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Blood uric acid increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Blood potassium increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Blood phosphorus decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Blood creatinine increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0023 events3 affected207 at risk
Blood urine present	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0005 events5 affected204 at risk EG0013 events3 affected201 at risk EG0023 events3 affected207 at risk
Blood cholesterol increased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Hyperphagia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0013 events3 affected201 at risk EG0021 events1 affected207 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0023 events3 affected207 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0023 events2 affected207 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0004 events2 affected204 at risk EG0010 events0 affected201 at risk EG0023 events3 affected207 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0022 events2 affected207 at risk
Muscle rigidity	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Myosclerosis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Posture abnormal	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Facial asymmetry	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0007 events6 affected204 at risk EG0014 events4 affected201 at risk EG0025 events5 affected207 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Syncope	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Speech disorder	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Somnolence	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0005 events5 affected204 at risk EG0014 events4 affected201 at risk EG0025 events5 affected207 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Presyncope	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Postural reflex impairment	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Poor quality sleep	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Parkinson's disease	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0012 events2 affected201 at risk EG0022 events2 affected207 at risk
Paraesthesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0017 events7 affected201 at risk EG0025 events5 affected207 at risk
Nerve root compression	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Nerve compression	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Migraine	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Micrographia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Meralgia paraesthetica	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Mental impairment	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
On and off phenomenon	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG00010 events9 affected204 at risk EG0012 events2 affected201 at risk EG0026 events6 affected207 at risk
Lethargy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Hemiparesis	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Headache	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0005 events5 affected204 at risk EG0014 events4 affected201 at risk EG0024 events4 affected207 at risk
Freezing phenomenon	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Dystonia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0023 events2 affected207 at risk
Dyskinesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG00014 events14 affected204 at risk EG00130 events23 affected201 at risk EG00237 events34 affected207 at risk
Sciatica	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Tremor	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Dysgeusia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Dizziness	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0005 events5 affected204 at risk EG0016 events6 affected201 at risk EG00211 events9 affected207 at risk
Disturbance in attention	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Cognitive disorder	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Bradykinesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0013 events3 affected201 at risk EG0020 events0 affected207 at risk
Balance disorder	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Akinesia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Apathy	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Anxiety	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0012 events2 affected201 at risk EG0026 events5 affected207 at risk
Abnormal dreams	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0024 events4 affected207 at risk
Terminal insomnia	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Sleep disorder	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0013 events3 affected201 at risk EG0021 events1 affected207 at risk
Restlessness	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Rapid eye movements sleep abnormal	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0022 events2 affected207 at risk
Paranoia	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Mood altered	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Middle insomnia	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Mania	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Libido increased	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Insomnia	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0006 events5 affected204 at risk EG00110 events10 affected201 at risk EG0027 events7 affected207 at risk
Initial insomnia	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Impulse-control disorder	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Illusion	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Hypomania	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Hypersexuality	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Hallucination	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0025 events4 affected207 at risk
Depression	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Depressed mood	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Delusion	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Confusional state	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Urinary retention	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Urge incontinence	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events1 affected201 at risk EG0020 events0 affected207 at risk
Renal failure	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Proteinuria	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Nephritis	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0010 events0 affected201 at risk EG0022 events2 affected207 at risk
Haematuria	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Azotaemia	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0013 events3 affected201 at risk EG0020 events0 affected207 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0021 events1 affected207 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0020 events0 affected207 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0013 events3 affected201 at risk EG0021 events1 affected207 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0014 events3 affected201 at risk EG0023 events3 affected207 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0023 events3 affected207 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Livedo reticularis	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events2 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0021 events1 affected207 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events1 affected201 at risk EG0020 events0 affected207 at risk
Peripheral coldness	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0002 events1 affected204 at risk EG0018 events7 affected201 at risk EG0023 events3 affected207 at risk
Orthostatic hypertension	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Hypotension	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0003 events3 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Hypoperfusion	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk
Hypertension	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0011 events1 affected201 at risk EG0025 events4 affected207 at risk
Hot flush	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0013 events3 affected201 at risk EG0022 events2 affected207 at risk
Haematoma	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Flushing	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0010 events0 affected201 at risk EG0021 events1 affected207 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0012 events2 affected201 at risk EG0020 events0 affected207 at risk
Accelerated hypertension	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected204 at risk EG0011 events1 affected201 at risk EG0020 events0 affected207 at risk

Istradefylline 40 mg and placebo to match istradefylline 20 mg:

A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.

Istradefylline 40 mg: Istradefylline 40 mg and placebo

Placebo: Placebo

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

ID	Title	Description
BG000	Placebo	Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Placebo: Placebo
BG001	Istradefylline 20 mg/Day	Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 20 mg: Istradefylline 20 mg and placebo Placebo: Placebo
BG002	Istradefylline 40 mg/Day	Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Istradefylline 40 mg: Istradefylline 40 mg and placebo Placebo: Placebo
BG003	Total	Total of all reporting groups