A Dose-Finding Study of RO4998452 in Patients With Diabet... | NCT00800176

NCT00800176

ID	Type	Description	Link
2008-001249-24

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions 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
Placebo	Placebo Comparator	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	Drug: Placebo
RO4998452 10mg	Experimental	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	Drug: RO4998452
RO4998452 2.5mg	Experimental	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	Drug: RO4998452
RO4998452 20mg	Experimental	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	po daily for 12 weeks	Placebo
RO4998452

Outcomes Module

Measure	Description	Time Frame
Absolute Change in HbA1c		Baseline, Week 4, Week 8 and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (mmol/L)		Baseline and Week 12
Change From Baseline in Mean Daily Glucose Concentration (mmol/L)		Baseline and Week 12

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

The safety population was used for baseline characteristics. The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.

Arm/Group Information

ID	Title	Description
BG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
BG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
BG002	RO4998452 5mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
BG003	RO4998452 10mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
BG004	RO4998452 20mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
BG005	RO4998452 40mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00053.9± 11.12 BG00153.3± 10.86 BG00254.8± 10.53 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00030 BG00132 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00042 BG00146 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Ex-Japan

Title	Measurements
	BG00054 BG00155 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

Absolute Change in HbA1c

Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

Posted

Mean

95% Confidence Interval

Percentage

Baseline, Week 4, Week 8 and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002	RO4998452 5mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
OG003	RO4998452 10mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
OG004	RO4998452 20mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
OG005	RO4998452 40mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.

Units	Counts
Participants	OG00065 OG00164 OG00265 OG003

Title	Denominators	Categories
Baseline	ParticipantsOG00065 ParticipantsOG00164 ParticipantsOG00265 ParticipantsOG003

Secondary

Change From Baseline in Fasting Plasma Glucose (mmol/L)

Posted

Mean

95% Confidence Interval

mmol/L

Baseline and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Change From Baseline in Mean Daily Glucose Concentration (mmol/L)

Posted

Mean

95% Confidence Interval

mmol/L

Baseline and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Change From Baseline in Fructosamine Concentration (μmol/L)

Posted

Mean

95% Confidence Interval

μmol/L

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)

Posted

Mean

95% Confidence Interval

mmol/L

Baseline and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)

Posted

Mean

95% Confidence Interval

mmol/L

Baseline and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)

Posted

Mean

95% Confidence Interval

mmol/L

Baseline and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Change From Baseline in Body Weight (kg)

Posted

Mean

95% Confidence Interval

Baseline and Week 12

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002	RO4998452 5mg

Secondary

Percentage of Participants Treated to Target HbA1c < 7%

Posted

Number

95% Confidence Interval

Percentage

Baseline up to 12 weeks

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Percentage of Participants Treated to Target HbA1c < 6.5%

Posted

Number

95% Confidence Interval

Percentage

Baseline up to 12 weeks

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002

Secondary

Percentage of Participants With at Least One Adverse Event

The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.

Posted

Number

Percentage

Baseline up to 12 weeks

ID	Title	Description
OG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
OG001	RO4998452 2.5 mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
OG002	RO4998452 5mg

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	1	66	25	66
EG001	RO4998452 2.5mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	2	66	24	66
EG002	RO4998452 5mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	0	65	30	65
EG003	RO4998452 10mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	0	66	25	66
EG004	RO4998452 20mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	0	64	23	64
EG005	RO4998452 40mg	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.	1	67	31	67

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
INGUINAL HERNIA	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG0030 events0 affected66 at risk EG0040 events0 affected64 at risk EG0051 events1 affected67 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NASOPHARYNGITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events2 affected66 at risk EG0021 events1 affected65 at risk EG0034 events4 affected66 at risk EG0040 events0 affected64 at risk EG0052 events2 affected67 at risk
URINARY TRACT INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0022 events2 affected65 at risk EG003
PHARYNGITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
BRONCHITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
GASTROENTERITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ORAL HERPES	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
PYELONEPHRITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
VULVOVAGINAL MYCOTIC INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
CERVICITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
DENGUE FEVER	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
FURUNCLE	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
GASTROINTESTINAL INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
GENITAL INFECTION FUNGAL	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
GENITOURINARY TRACT INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INFLUENZA	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
OTITIS EXTERNA BACTERIAL	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
OTITIS MEDIA	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
PYELONEPHRITIS ACUTE	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
RHINITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
SINUSITIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
TINEA PEDIS	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
VIRAL INFECTION	Infections and infestations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
NAUSEA	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0022 events2 affected65 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
FOOD POISONING	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
GINGIVAL PAIN	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
VOMITING	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
DENTAL CARIES	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INTRA-ABDOMINAL HAEMATOMA	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
SALIVA ALTERED	Gastrointestinal disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
HEADACHE	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0002 events2 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
DIZZINESS	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events2 affected66 at risk EG0020 events0 affected65 at risk EG003
DIABETIC NEUROPATHY	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
SINUS HEADACHE	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
APHONIA	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
BURNING SENSATION	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
FACIAL PALSY	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
HYPERSOMNIA	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
PARAESTHESIA	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
SCIATICA	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
SOMNOLENCE	Nervous system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INTERVERTEBRAL DISC	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
MUSCLE CONTRACTURE	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
OSTEOCHONDROSIS	Musculoskeletal and connective tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0002 events2 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INCREASED APPETITE	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
POLYDIPSIA	Metabolism and nutrition disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
BLOOD FIBRINOGEN INCREASED	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
ELECTROCARDIOGRAM T WAVE ABNORMAL	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
BLOOD UREA INCREASED	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ELECTROCARDIOGRAM QT PROLONGED	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ELECTROCARDIOGRAM T WAVE BIPHASIC	Investigations	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
LYMPH NODE PALPABLE	Investigations	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
URINE OUTPUT INCREASED	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
WEIGHT DECREASED	Investigations	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
POLLAKIURIA	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
MICTURITION URGENCY	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
NOCTURIA	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
POLYURIA	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
RENAL COLIC	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
RENAL IMPAIRMENT	Renal and urinary disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
SINUS BRADYCARDIA	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
SINUS TACHYCARDIA	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
PALPITATIONS	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
HUNGER	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
THIRST	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
FATIGUE	General disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
ASTHENIA	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
MALAISE	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
VESSEL PUNCTURE SITE HAEMATOMA	General disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
EXCORIATION	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events2 affected66 at risk EG0020 events0 affected65 at risk EG003
ANIMAL BITE	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
EPICONDYLITIS	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
FALL	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
INJURY	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
JOINT SPRAIN	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
PERIORBITAL HAEMATOMA	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
THERMAL BURN	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
WOUND	Injury, poisoning and procedural complications	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ANXIETY	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
INSOMNIA	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
AGITATION	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
DEPRESSED MOOD	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
DEPRESSION	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
LIBIDO DECREASED	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
LOSS OF LIBIDO	Psychiatric disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedRA 12.1	Systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
UPPER RESPIRATORY TRACT INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
VISION BLURRED	Eye disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0021 events1 affected65 at risk EG003
CONJUNCTIVITIS	Eye disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
DIABETIC RETINOPATHY	Eye disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
GLAUCOMA	Eye disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
OCULAR DISCOMFORT	Eye disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
OCULAR HYPERAEMIA	Eye disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
VISUAL ACUITY REDUCED	Eye disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ECZEMA	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
RASH MACULAR	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
SKIN EROSION	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
SKIN ULCER	Skin and subcutaneous tissue disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
ANAEMIA	Blood and lymphatic system disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedRA 12.1	Systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
MENORRHAGIA	Reproductive system and breast disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
METRORRHAGIA	Reproductive system and breast disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
PRURITUS GENITAL	Reproductive system and breast disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
VULVOVAGINAL PRURITUS	Reproductive system and breast disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPERTENSION	Vascular disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HOT FLUSH	Vascular disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPOTENSION	Vascular disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
PHIMOSIS	Congenital, familial and genetic disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
TYPE II HYPERLIPIDAEMIA	Congenital, familial and genetic disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
TYPE IV HYPERLIPIDAEMIA	Congenital, familial and genetic disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0021 events1 affected65 at risk EG003
BILIARY COLIC	Hepatobiliary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
HEPATIC STEATOSIS	Hepatobiliary disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
DENTAL IMPLANTATION	Surgical and medical procedures	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
TOOTH EXTRACTION	Surgical and medical procedures	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003
HYPOTHYROIDISM	Endocrine disorders	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected66 at risk EG0020 events0 affected65 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedRA 12.1	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected66 at risk EG0020 events0 affected65 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.