Trial Outcomes & Findings for Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder (NCT NCT00088465)

NCT ID: NCT00088465

Last Updated: 2012-01-11

Results Overview

The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 931 participants
• Primary outcome timeframe: Randomization to end of study up to 76 months
• Results posted on: 2012-01-11

Participant Flow

Participant milestones

Measure	Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Overall Study STARTED	931
Overall Study COMPLETED	370
Overall Study NOT COMPLETED	561

Reasons for withdrawal

Measure	Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Overall Study Withdrawal by Subject	290
Overall Study Adverse Event	77
Overall Study Lost to Follow-up	57
Overall Study Physician Decision	45
Overall Study Sponsor Decision	37
Overall Study Lack of Efficacy	27
Overall Study Protocol Violation	17
Overall Study Death	11

Baseline Characteristics

Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

Baseline characteristics by cohort

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Age Continuous	39.32 years STANDARD_DEVIATION 11.67 • n=5 Participants
Sex: Female, Male Female	310 Participants n=5 Participants
Sex: Female, Male Male	621 Participants n=5 Participants
Race/Ethnicity, Customized African	102 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	629 participants n=5 Participants
Race/Ethnicity, Customized East Asian	39 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	140 participants n=5 Participants
Race/Ethnicity, Customized Native American	2 participants n=5 Participants
Race/Ethnicity, Customized West Asian	19 participants n=5 Participants
Region of Enrollment United States	177 participants n=5 Participants
Region of Enrollment Portugal	18 participants n=5 Participants
Region of Enrollment Taiwan	30 participants n=5 Participants
Region of Enrollment Slovakia	13 participants n=5 Participants
Region of Enrollment Spain	24 participants n=5 Participants
Region of Enrollment Russian Federation	114 participants n=5 Participants
Region of Enrollment Israel	29 participants n=5 Participants
Region of Enrollment Italy	6 participants n=5 Participants
Region of Enrollment France	55 participants n=5 Participants
Region of Enrollment Puerto Rico	27 participants n=5 Participants
Region of Enrollment Australia	11 participants n=5 Participants
Region of Enrollment South Africa	28 participants n=5 Participants
Region of Enrollment Netherlands	8 participants n=5 Participants
Region of Enrollment Austria	10 participants n=5 Participants
Region of Enrollment Czech Republic	3 participants n=5 Participants
Region of Enrollment Hungary	13 participants n=5 Participants
Region of Enrollment Mexico	63 participants n=5 Participants
Region of Enrollment Argentina	73 participants n=5 Participants
Region of Enrollment Poland	33 participants n=5 Participants
Region of Enrollment Brazil	89 participants n=5 Participants
Region of Enrollment Belgium	13 participants n=5 Participants
Region of Enrollment Croatia	16 participants n=5 Participants
Region of Enrollment Romania	34 participants n=5 Participants
Region of Enrollment Germany	32 participants n=5 Participants
Region of Enrollment Sweden	9 participants n=5 Participants
Region of Enrollment Greece	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: All randomized participants who took at least one dose of study drug.

The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants With Adverse Events (AE) AE	501 participants
Number of Participants With Adverse Events (AE) SAE	170 participants

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants with normal baseline and at least one post-baseline measurement.

Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=430 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline	100 participants

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants with normal baseline and at least one post-baseline measurement.

High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline ALT (n=901)	61 participants
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline AST (n=909)	55 participants
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline Total Bilirubin (n=912)	24 participants

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants with normal baseline and at least one post-baseline measurement.

Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=864 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline	20 participants

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants with normal baseline and at least one post-baseline measurement.

Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline Cholesterol (n=873)	28 participants
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline Triglycerides (n=879)	41 participants

PRIMARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=919 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in Weight at Month 76 Endpoint	2.10 kilogram (kg) Standard Deviation 7.81

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants with normal baseline and at least one post-baseline measurement.

PCS weight gain is defined as a ≥7% increase in weight from baseline.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=919 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint	373 participants

PRIMARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants with a baseline and at least one post-baseline measurement.

Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Participants With Extrapyramidal Symptoms at Any Time SAS (n=819)	66 participants
Number of Participants With Extrapyramidal Symptoms at Any Time BAS (n=856)	34 participants
Number of Participants With Extrapyramidal Symptoms at Any Time AIMS (n=860)	28 participants

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=856 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint	0.30 units on a scale Standard Deviation 16.42

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=856 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint	0.21 units on a scale Standard Deviation 4.69

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=856 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint	-0.08 units on a scale Standard Deviation 5.14

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=856 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint	0.19 units on a scale Standard Deviation 8.51

SECONDARY outcome

Timeframe: Baseline, up to 72 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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).

Outcome measures

Measure	Intramuscular Olanzapine Depot n=920 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint	-0.17 units on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=852 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint	6.75 units on a scale Standard Deviation 18.55

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=850 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint Mental component summary	0.94 units on a scale Standard Deviation 11.05
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint Physical component summary	-0.36 units on a scale Standard Deviation 8.34

SECONDARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: All randomized participants who took at least one dose of study drug.

Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Number of Psychiatric Visits	14102 visits

SECONDARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: All randomized participants who took at least one dose of study drug.

This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Days of Hospitalization Regular hospital	2386 days
Days of Hospitalization Psychiatric hospital	35587 days
Days of Hospitalization ICU	134 days

SECONDARY outcome

Timeframe: Baseline, up to 76 months

Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=755 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint	0.86 units on a scale Standard Deviation 15.96

SECONDARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: All randomized participants.

Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint Depot, somewhat or very satisfied	73.2 percent of participants
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint Depot vs. oral, prefer or much prefer	66.8 percent of participants
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint Depot vs. oral, less or much less side effects	73.3 percent of participants

SECONDARY outcome

Timeframe: Randomization to end of study up to 76 months

Population: Participants who took at least one dose of study drug and had post-baseline measurements.

Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).

Outcome measures

Measure	Intramuscular Olanzapine Depot n=931 Participants Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 0.25 year (n= 130)	2.23 (ng/mL)/(mg/day) Standard Deviation 1.34
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 1 year (n= 189)	2.51 (ng/mL)/(mg/day) Standard Deviation 1.30
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 2 years (n= 166)	2.45 (ng/mL)/(mg/day) Standard Deviation 1.32
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 3 years (n= 148)	2.65 (ng/mL)/(mg/day) Standard Deviation 1.39
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 4 years (n= 109)	2.57 (ng/mL)/(mg/day) Standard Deviation 1.72
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 5 years (n= 87)	2.59 (ng/mL)/(mg/day) Standard Deviation 1.46
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year 6 years (n= 28)	2.73 (ng/mL)/(mg/day) Standard Deviation 1.25

Adverse Events

Intramuscular Olanzapine Depot

Serious events: 170 serious events

Other events: 501 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intramuscular Olanzapine Depot n=931 participants at risk Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Blood and lymphatic system disorders Iron deficiency anaemia	0.11% 1/931 • Number of events 1
Cardiac disorders Cardiac failure	0.11% 1/931 • Number of events 1
Cardiac disorders Cardiac failure acute	0.11% 1/931 • Number of events 1
Cardiac disorders Cardiomyopathy alcoholic	0.11% 1/931 • Number of events 1
Cardiac disorders Hypertrophic cardiomyopathy	0.11% 1/931 • Number of events 1
Cardiac disorders Myocardial infarction	0.32% 3/931 • Number of events 3
Cardiac disorders Myocardial ischaemia	0.11% 1/931 • Number of events 1
Cardiac disorders Ventricular tachycardia	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Abdominal discomfort	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Abdominal pain	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Abdominal pain upper	0.11% 1/931 • Number of events 2
Gastrointestinal disorders Diarrhoea	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Dry mouth	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Inguinal hernia	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Intestinal ischaemia	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Intestinal perforation	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Subileus	0.11% 1/931 • Number of events 1
Gastrointestinal disorders Toothache	0.11% 1/931 • Number of events 1
General disorders Asthenia	0.21% 2/931 • Number of events 2
General disorders Fatigue	0.21% 2/931 • Number of events 2
General disorders Malaise	0.32% 3/931 • Number of events 3
Hepatobiliary disorders Hepatotoxicity	0.11% 1/931 • Number of events 1
Infections and infestations Abscess	0.11% 1/931 • Number of events 1
Infections and infestations Abscess limb	0.11% 1/931 • Number of events 1
Infections and infestations Appendicitis	0.21% 2/931 • Number of events 2
Infections and infestations Breast cellulitis	0.11% 1/931 • Number of events 1
Infections and infestations Cellulitis	0.32% 3/931 • Number of events 3
Infections and infestations Ear infection	0.11% 1/931 • Number of events 1
Infections and infestations Gastroenteritis	0.11% 1/931 • Number of events 1
Infections and infestations Leptospirosis	0.11% 1/931 • Number of events 1
Infections and infestations Lobar pneumonia	0.11% 1/931 • Number of events 1
Infections and infestations Pneumonia	0.21% 2/931 • Number of events 2
Infections and infestations Pyelonephritis acute	0.21% 2/931 • Number of events 2
Infections and infestations Septic shock	0.11% 1/931 • Number of events 1
Infections and infestations Urinary tract infection	0.21% 2/931 • Number of events 2
Injury, poisoning and procedural complications Brain contusion	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Drug exposure during pregnancy	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Fall	0.21% 2/931 • Number of events 2
Injury, poisoning and procedural complications Joint dislocation	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Lower limb fracture	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Overdose	0.32% 3/931 • Number of events 3
Injury, poisoning and procedural complications Post procedural complication	0.21% 2/931 • Number of events 4
Injury, poisoning and procedural complications Rib fracture	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Road traffic accident	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Skull fractured base	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Subdural haematoma	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Tendon rupture	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Tibia fracture	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Traumatic brain injury	0.11% 1/931 • Number of events 1
Injury, poisoning and procedural complications Traumatic lung injury	0.11% 1/931 • Number of events 1
Investigations Blood glucose increased	0.11% 1/931 • Number of events 1
Investigations Blood potassium decreased	0.11% 1/931 • Number of events 1
Investigations Blood pressure decreased	0.11% 1/931 • Number of events 1
Investigations Laboratory test abnormal	0.11% 1/931 • Number of events 1
Metabolism and nutrition disorders Diabetes mellitus	0.21% 2/931 • Number of events 2
Metabolism and nutrition disorders Diabetic ketoacidosis	0.11% 1/931 • Number of events 1
Metabolism and nutrition disorders Electrolyte imbalance	0.11% 1/931 • Number of events 1
Metabolism and nutrition disorders Hypokalaemia	0.11% 1/931 • Number of events 1
Metabolism and nutrition disorders Polydipsia	0.11% 1/931 • Number of events 1
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.11% 1/931 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle spasms	0.11% 1/931 • Number of events 1
Musculoskeletal and connective tissue disorders Osteoarthritis	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.21% 2/931 • Number of events 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.11% 1/931 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.11% 1/931 • Number of events 1
Nervous system disorders Cauda equina syndrome	0.11% 1/931 • Number of events 2
Nervous system disorders Cerebral haematoma	0.11% 1/931 • Number of events 1
Nervous system disorders Cerebrovascular accident	0.11% 1/931 • Number of events 1
Nervous system disorders Cervicobrachial syndrome	0.11% 1/931 • Number of events 2
Nervous system disorders Coma	0.11% 1/931 • Number of events 1
Nervous system disorders Dizziness	0.32% 3/931 • Number of events 3
Nervous system disorders Dysarthria	0.11% 1/931 • Number of events 1
Nervous system disorders Headache	0.11% 1/931 • Number of events 2
Nervous system disorders Loss of consciousness	0.21% 2/931 • Number of events 2
Nervous system disorders Parkinsonism	0.11% 1/931 • Number of events 2
Nervous system disorders Sedation	1.3% 12/931 • Number of events 13
Nervous system disorders Somnolence	0.54% 5/931 • Number of events 5
Nervous system disorders Subarachnoid haemorrhage	0.11% 1/931 • Number of events 1
Nervous system disorders Tremor	0.11% 1/931 • Number of events 1
Psychiatric disorders Abnormal behaviour	0.11% 1/931 • Number of events 1
Psychiatric disorders Acute stress disorder	0.11% 1/931 • Number of events 1
Psychiatric disorders Aggression	0.43% 4/931 • Number of events 5
Psychiatric disorders Agitation	0.64% 6/931 • Number of events 7
Psychiatric disorders Alcohol abuse	0.11% 1/931 • Number of events 1
Psychiatric disorders Anxiety	0.54% 5/931 • Number of events 6
Psychiatric disorders Completed suicide	0.11% 1/931 • Number of events 1
Psychiatric disorders Confusional state	0.43% 4/931 • Number of events 5
Psychiatric disorders Delirium	0.43% 4/931 • Number of events 4
Psychiatric disorders Delusion	0.11% 1/931 • Number of events 1
Psychiatric disorders Depression	0.54% 5/931 • Number of events 5
Psychiatric disorders Disorientation	0.11% 1/931 • Number of events 2
Psychiatric disorders Emotional disorder	0.11% 1/931 • Number of events 1
Psychiatric disorders Hallucination	0.11% 1/931 • Number of events 1
Psychiatric disorders Hallucination, auditory	0.21% 2/931 • Number of events 2
Psychiatric disorders Impulsive behaviour	0.11% 1/931 • Number of events 2
Psychiatric disorders Mental status changes	0.11% 1/931 • Number of events 1
Psychiatric disorders Paranoia	0.54% 5/931 • Number of events 5
Psychiatric disorders Psychotic disorder	2.1% 20/931 • Number of events 21
Psychiatric disorders Restlessness	0.11% 1/931 • Number of events 2
Psychiatric disorders Schizophrenia	3.8% 35/931 • Number of events 38
Psychiatric disorders Schizophrenia, paranoid type	0.11% 1/931 • Number of events 1
Psychiatric disorders Suicidal behaviour	0.11% 1/931 • Number of events 1
Psychiatric disorders Suicidal ideation	0.86% 8/931 • Number of events 9
Psychiatric disorders Suicide attempt	0.43% 4/931 • Number of events 4
Psychiatric disorders Vomiting psychogenic	0.11% 1/931 • Number of events 1
Renal and urinary disorders Urinary incontinence	0.11% 1/931 • Number of events 1
Renal and urinary disorders Urinary retention	0.11% 1/931 • Number of events 2
Reproductive system and breast disorders Menorrhagia	0.11% 1/931 • Number of events 1
Respiratory, thoracic and mediastinal disorders Asthma	0.11% 1/931 • Number of events 1
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.11% 1/931 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.11% 1/931 • Number of events 1
Respiratory, thoracic and mediastinal disorders Haemothorax	0.11% 1/931 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.11% 1/931 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.11% 1/931 • Number of events 1
Skin and subcutaneous tissue disorders Acne	0.11% 1/931 • Number of events 1
Skin and subcutaneous tissue disorders Dermatitis	0.21% 2/931 • Number of events 3
Social circumstances Social stay hospitalisation	0.11% 1/931 • Number of events 1
Surgical and medical procedures Plastic surgery	0.11% 1/931 • Number of events 1
Vascular disorders Hypertension	0.32% 3/931 • Number of events 4
Vascular disorders Peripheral arterial occlusive disease	0.11% 1/931 • Number of events 1
Vascular disorders Thrombophlebitis	0.11% 1/931 • Number of events 1
Vascular disorders Venous thrombosis limb	0.11% 1/931 • Number of events 1

Other adverse events

Measure	Intramuscular Olanzapine Depot n=931 participants at risk Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Infections and infestations Nasopharyngitis	7.9% 74/931 • Number of events 84
Investigations Weight increased	14.4% 134/931 • Number of events 136
Nervous system disorders Dizziness	5.4% 50/931 • Number of events 57
Nervous system disorders Headache	7.2% 67/931 • Number of events 72
Nervous system disorders Somnolence	9.1% 85/931 • Number of events 101
Psychiatric disorders Anxiety	9.7% 90/931 • Number of events 94
Psychiatric disorders Depression	5.2% 48/931 • Number of events 48
Psychiatric disorders Insomnia	9.7% 90/931 • Number of events 92

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60