Study in Adolescents With Schizophrenia or Bipolar Disorder | NCT00982020

NCT00982020

ID	Type	Description	Link
F1D-MC-HGMX	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

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
Olanzapine/standard behavioral weight intervention	Experimental		Drug: Olanzapine Behavioral: Standard behavioral weight intervention
Olanzapine/intense behavioral weight intervention	Experimental		Drug: Olanzapine Behavioral: Intense behavioral weight intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine	Drug	2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks	Olanzapine/intense behavioral weight intervention Olanzapine/standard behavioral weight intervention

Outcomes Module

Measure	Description	Time Frame
Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants		Baseline, 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months		Baseline, 52 weeks
Time to Event for 7%, 15%, and 25% Weight Gain for All Participants	Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) or a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL).
Participants with a diagnosis of schizophrenia must obtain a Brief Psychiatric Rating Scale for Children (BPRS-C) total score >30, with a minimum score of 3 on at least one of the following items at both screening and randomization - hallucinations, delusions, peculiar fantasies.
Participants with a diagnosis of bipolar I disorder must have a Young Mania Rating Scale (YMRS) total score greater than or equal to 15 at both screening and randomization.
Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit participant to perform all tests and examinations required by the protocol, and understands the nature of the study.

Exclusion Criteria:

History of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.
Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to randomization.
Been judged clinically to be at any suicidal risk.
History of allergic reaction or hypersensitivity to olanzapine.
Receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.
Other antipsychotics, mood stabilizers, or anticonvulsants (for mood stabilization) used for the primary study conditions (bipolar I disorder or schizophrenia)
Have acute, serious, or unstable medical conditions
Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 12 months (365 days).
Have had one or more seizures without a clear and resolved etiology.
Baseline alanine aminotransferase (ALT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at screening.
Have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count <500 cubic millimeter [mm^3], <0.5 GI/L, or <0.5 10E^3/microliters [μL]) during the participant's lifetime.
Prolactin level of >200 nanograms per milliliter (ng/mL) [>200 micrograms per liter (ug/L), or >4228 milli-International unit per liter (mIU/L)] at screening.
Have QTc (Bazett's) >450 milliseconds (males) or >460 milliseconds (females) at screening.
Previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to screening.
Currently prescribed olanzapine for greater than or equal to 5 days within 1 month (30 days) prior to screening.
Are investigator site personnel directly affiliated with this study and/or their immediate families OR are employed by or representatives of Lilly.
Pregnant or nursing.
Have received treatment within the last 30 days with an investigational new drug that has not received regulatory approval for any indication at the time of study entry.
Treatment with clozapine within 14 days prior to randomization.
Participants who have used olanzapine (that is, oral olanzapine, intramuscular [IM] olanzapine, or olanzapine orally disintegrating tablets) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine including treatment resistance.

Contacts/Locations 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

Locations

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.		Lauderhill	Florida	33319

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27676420	Derived	Detke HC, DelBello MP, Landry J, Hoffmann VP, Heinloth A, Dittmann RW. A 52-Week Study of Olanzapine with a Randomized Behavioral Weight Counseling Intervention in Adolescents with Schizophrenia or Bipolar I Disorder. J Child Adolesc Psychopharmacol. 2016 Dec;26(10):922-934. doi: 10.1089/cap.2016.0010. Epub 2016 Sep 27.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
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

Masking Info

All randomized participants who received at least one dose of study drug

Arm/Group Information

ID	Title	Description
BG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
BG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000102 BG001101 BG002203

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
	BG00015.86± 1.49 BG00115.66± 1.52 BG00215.76± 1.51

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00050 BG00147 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00015 BG0019 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Germany

Title	Measurements
	BG0002 BG0011 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

Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants

All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.

Posted

Least Squares Mean

Standard Error

kilograms per meter squared (kg/m^2)

Baseline, 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Units	Counts
Participants	OG000102 OG001101

Title

Denominators

Categories

Title	Measurements
	OG0003.64± .39 OG0012.83± .40

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		Mixed Models Analysis	Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group*visit.	0.150	The threshold for statistical significance was 0.05.												No	Superiority or Other

Secondary

Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months

All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology.

Posted

Least Squares Mean

Standard Error

kg/m^2

Baseline, 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Units	Counts
Participants

Secondary

Time to Event for 7%, 15%, and 25% Weight Gain for All Participants

Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).

65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued.

122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.

161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued.

Posted

Median

95% Confidence Interval

days

Baseline up to 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Secondary

Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder

The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).

All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.

Secondary

Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants

The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).

All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.

Posted

Least Squares Mean

Standard Error

units on a scale

52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Units

Secondary

Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants

All randomized participants who received at least one dose of study drug.

Posted

Least Squares Mean

Standard Error

centimeters (cm)

Baseline, 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants

The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.

All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Units

Secondary

Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia

The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.

All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 52 weeks

ID	Title	Description
OG000	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
OG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

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	Olanzapine/Standard Behavioral Weight Intervention	Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only			13	102	81	102
EG001	Olanzapine/Intense Behavioral Weight Intervention	Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.			20	101	81	101

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastroduodenitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Irritability	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0012 events1 affected101 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Traumatic lung injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Neuroleptic malignant syndrome	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0012 events1 affected101 at risk
Aggression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0012 events2 affected101 at risk
Bipolar i disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0014 events4 affected101 at risk
Drug abuse	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Mental disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected101 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0015 events4 affected101 at risk
Schizophrenia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected102 at risk EG0012 events2 affected101 at risk
Suicide attempt	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected102 at risk EG0010 events0 affected101 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected101 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dry mouth	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected102 at risk EG0014 events4 affected101 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0008 events7 affected102 at risk EG0017 events4 affected101 at risk
Fatigue	General disorders	MedDRA 16.0	Systematic Assessment	EG00010 events9 affected102 at risk EG0016 events6 affected101 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00016 events14 affected102 at risk EG00111 events11 affected101 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0009 events7 affected102 at risk EG0016 events5 affected101 at risk
Blood insulin increased	Investigations	MedDRA 16.0	Systematic Assessment	EG00011 events10 affected102 at risk EG0017 events7 affected101 at risk
Weight increased	Investigations	MedDRA 16.0	Systematic Assessment	EG00031 events31 affected102 at risk EG00121 events21 affected101 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00016 events16 affected102 at risk EG00114 events13 affected101 at risk
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected102 at risk EG0012 events2 affected101 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00049 events19 affected102 at risk EG00130 events20 affected101 at risk
Sedation	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0008 events8 affected102 at risk EG0015 events3 affected101 at risk
Somnolence	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00022 events19 affected102 at risk EG00128 events24 affected101 at risk
Anxiety	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected102 at risk EG0014 events3 affected101 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG00018 events3 affected50 at risk EG0014 events1 affected47 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0008 events7 affected102 at risk EG0015 events3 affected101 at risk

ID	Term
D012559	Schizophrenia
D000087122	Mania

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077152	Olanzapine

Units	Counts
Participants	OG00044 OG00143

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds