Assessment of Safety and Efficacy of Therapy for the Prev... | NCT00401973

ID	Type	Description	Link
F1D-US-HGMM

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olanzapine	Experimental	olanzapine plus behavioral information	Drug: olanzapine Behavioral: Wellness education
Olanzapine + Amantadine	Experimental	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information	Drug: olanzapine Drug: amantadine Drug: metformin Drug: zonisamide Behavioral: Wellness education
Olanzapine + Metformin	Experimental	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information	Drug: olanzapine Drug: amantadine Drug: metformin Drug: zonisamide Behavioral: Wellness education

Name	Type	Description	Arm Group Labels	Other Names
olanzapine	Drug	5-20 milligrams (mg), oral, daily for 22 weeks.	Olanzapine Olanzapine + Amantadine Olanzapine + Metformin

Measure	Description	Time Frame
Change From Baseline to Endpoint in Weight		Baseline to endpoint (22 weeks)

Measure	Description	Time Frame
Mean Change From Baseline to Endpoint in Fasting Triglycerides		Baseline to endpoint (22 weeks)
Mean Change From Baseline to Endpoint in Fasting Total Cholesterol		Baseline to endpoint (22 weeks)

Eligibility Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		National City	California	91950

PubMed Identifier	Type	Citation	Retractions
21672497	Derived	Hoffmann VP, Case M, Jacobson JG. Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. J Clin Psychiatry. 2012 Feb;73(2):216-23. doi: 10.4088/JCP.09m05580. Epub 2011 May 17.
20840778	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
FG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
BG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
BG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00050 BG00176 BG00273 BG003199

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
	BG00038.7± 12.89 BG00138.2± 11.40 BG00238.7± 12.01 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00019 BG00130 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00013 BG00122 BG002

Race/Ethnicity

Number

participants

Title

Denominators

Categories

African

Title	Measurements
	BG0002 BG00110 BG002

Type of Diagnosis

Number

participants

Title

Denominators

Categories

Schizoaffective

Title	Measurements
	BG0008 BG00115 BG002

Body Mass Index (BMI)

Body mass index is an estimate of body fat based on body weight divided by height squared.

Mean

Standard Deviation

kilograms/square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00027.0± 4.53 BG00127.3± 4.67

Onset Age

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00024.35± 8.42 BG00126.44± 9.98 BG002

Previous Number of Episodes

Mean

Standard Deviation

number of episodes

Title

Denominators

Categories

Title	Measurements
	BG0001.53± 1.02 BG0012.19± 5.90 BG002

Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00077.0± 16.33 BG00179.1± 17.27 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 to Endpoint in Weight

All randomized participants with baseline and at least one postbaseline measurement.

Posted

Least Squares Mean

Standard Error

kilograms

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Units	Counts
Participants	OG00040 OG00150 OG00251

Title

Denominators

Categories

Title	Measurements
	OG0002.76± 0.75 OG0012.40± 0.65 OG0020.65± 0.63

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002	To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine & adjunctive treatment' arm at Week 22.	Mixed Models Analysis	Repeated Measures Analysis	0.065	P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.						95						No

Secondary

Mean Change From Baseline to Endpoint in Fasting Triglycerides

All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

millimoles per Liter (mmol/L)

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Mean Change From Baseline to Endpoint in Fasting Total Cholesterol

All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

millimole per Liter (mmol/L)

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol

Number of randomized participants with a baseline and at least one post-baseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

millimole per liter (mmol/L)

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol

All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

millimole per Liter (mmol/L)

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Mean Change From Baseline to Endpoint in Fasting Glucose

All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

millimole per Liter (mmol/L)

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Mean Change From Baseline to Endpoint in Hemoglobin A1c

All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

percent hemoglobin A1c

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score

The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.

Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

units on a scale

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

units on a scale

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.

Posted

Mean

Standard Deviation

units on a scale

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
OG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).
OG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).

Secondary

Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks

To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.

N=Pairs of Observations for the combined treatment groups.

Posted

Number

correlation

Baseline to endpoint (22 weeks)

ID	Title	Description
OG000	2 Weeks	Combined treatment groups: olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks]. Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]. Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].
OG001

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Olanzapine	olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.	5	26
EG001	Olanzapine + Amantadine	Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).	4	38
EG002	Olanzapine + Metformin	Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms).	4	46

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest pain	General disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected76 at risk EG0021 events1 affected73 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected76 at risk EG0020 events0 affected73 at risk
Akathisia	Nervous system disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected76 at risk EG0020 events0 affected73 at risk
Hallucination	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected76 at risk EG0022 events2 affected73 at risk
Panic attack	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected76 at risk EG0020 events0 affected73 at risk
Psychotic disorder	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected76 at risk EG0020 events0 affected73 at risk
Schizophrenia	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected76 at risk EG0020 events0 affected73 at risk
Suicidal ideation	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected76 at risk EG0020 events0 affected73 at risk
Suicide attempt	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected76 at risk EG0021 events1 affected73 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected76 at risk EG0023 events3 affected73 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected76 at risk EG00211 events10 affected73 at risk
Dry mouth	Gastrointestinal disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0014 events4 affected76 at risk EG0020 events0 affected73 at risk
Nausea	Gastrointestinal disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0013 events3 affected76 at risk EG0026 events5 affected73 at risk
Vomiting	Gastrointestinal disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected76 at risk EG0025 events5 affected73 at risk
Asthenia	General disorders	MedDRA11.0	Systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected76 at risk EG0023 events3 affected73 at risk
Fatigue	General disorders	MedDRA11.0	Systematic Assessment	EG0001 events1 affected50 at risk EG0012 events2 affected76 at risk EG0023 events3 affected73 at risk
Nasopharyngitis	Infections and infestations	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0014 events4 affected76 at risk EG0020 events0 affected73 at risk
Urinary tract infection	Infections and infestations	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected76 at risk EG0020 events0 affected73 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected76 at risk EG0020 events0 affected73 at risk
Weight increased	Investigations	MedDRA11.0	Systematic Assessment	EG0003 events2 affected50 at risk EG0014 events4 affected76 at risk EG0024 events4 affected73 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA11.0	Systematic Assessment	EG0004 events3 affected50 at risk EG0011 events1 affected76 at risk EG0023 events3 affected73 at risk
Akathisia	Nervous system disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0013 events3 affected76 at risk EG0022 events2 affected73 at risk
Dizziness	Nervous system disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0011 events1 affected76 at risk EG0022 events2 affected73 at risk
Headache	Nervous system disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0012 events2 affected76 at risk EG0024 events4 affected73 at risk
Sedation	Nervous system disorders	MedDRA11.0	Systematic Assessment	EG0000 events0 affected50 at risk EG0014 events4 affected76 at risk EG0022 events2 affected73 at risk
Somnolence	Nervous system disorders	MedDRA11.0	Systematic Assessment	EG0004 events4 affected50 at risk EG0015 events5 affected76 at risk EG00210 events8 affected73 at risk
Anxiety	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0013 events3 affected76 at risk EG0022 events2 affected73 at risk
Insomnia	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0005 events5 affected50 at risk EG0015 events4 affected76 at risk EG0023 events1 affected73 at risk
Sleep disorder	Psychiatric disorders	MedDRA11.0	Systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected76 at risk EG0021 events1 affected73 at risk

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D013449	Sulfonamides
D000577	Amides
D013450	Sulfones
D013457	Sulfur Compounds
D007555	Isoxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

ID	Term
D000077152	Olanzapine
D000547	Amantadine
D008687	Metformin
D000078305	Zonisamide