Trial Outcomes & Findings for Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder (NCT NCT06319170)
NCT ID: NCT06319170
Last Updated: 2026-01-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
106 participants
Primary outcome timeframe
Randomization Day 1 to 84 days after randomization
Results posted on
2026-01-26
Participant Flow
A total of 183 participants signed the informed consent form for screening. Of these, 106 participants met eligibility criteria and were enrolled in the study. 91 participants were randomized to treatment arms.
Participant milestones
| Measure |
ZYPREXA
Participants received a single injection of 5 milligrams (mg) of ZYPREXA, immediate-release solution, administered intramuscularly (IM) to the gluteal muscle.
|
Cohort 1: Olanzapine (Fast-D)
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered subcutaneously (SC) to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
Cohort 3: Olanzapine (Slow-C)
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|---|
|
1-Day Treatment Period
STARTED
|
106
|
0
|
0
|
0
|
|
1-Day Treatment Period
Received at Least 1 Dose of Study Drug
|
98
|
0
|
0
|
0
|
|
1-Day Treatment Period
COMPLETED
|
91
|
0
|
0
|
0
|
|
1-Day Treatment Period
NOT COMPLETED
|
15
|
0
|
0
|
0
|
|
28-Day Treatment Period
STARTED
|
0
|
29
|
31
|
31
|
|
28-Day Treatment Period
Received at Least 1 Dose of Study Drug
|
0
|
29
|
31
|
31
|
|
28-Day Treatment Period
COMPLETED
|
0
|
28
|
29
|
31
|
|
28-Day Treatment Period
NOT COMPLETED
|
0
|
1
|
2
|
0
|
|
8-Week Follow-up Period
STARTED
|
0
|
28
|
29
|
31
|
|
8-Week Follow-up Period
COMPLETED
|
0
|
27
|
27
|
30
|
|
8-Week Follow-up Period
NOT COMPLETED
|
0
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
ZYPREXA
Participants received a single injection of 5 milligrams (mg) of ZYPREXA, immediate-release solution, administered intramuscularly (IM) to the gluteal muscle.
|
Cohort 1: Olanzapine (Fast-D)
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered subcutaneously (SC) to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
Cohort 3: Olanzapine (Slow-C)
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|---|
|
1-Day Treatment Period
Enrolled But Not Treated
|
8
|
0
|
0
|
0
|
|
1-Day Treatment Period
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
|
1-Day Treatment Period
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
1-Day Treatment Period
Other Than Specified
|
2
|
0
|
0
|
0
|
|
28-Day Treatment Period
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
|
28-Day Treatment Period
Other Than Specified
|
0
|
1
|
0
|
0
|
|
8-Week Follow-up Period
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
8-Week Follow-up Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
8-Week Follow-up Period
Other Than Specified
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
Baseline characteristics by cohort
| Measure |
ZYPREXA Only (Not Randomized)
n=15 Participants
Participants received a single injection of 5 mg of ZYPREXA, immediate-release solution, administered IM to the gluteal muscle.
|
Cohort 1: Olanzapine (Fast-D)
n=29 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
Cohort 3: Olanzapine (Slow-C)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 11.95 • n=41 Participants
|
45.7 years
STANDARD_DEVIATION 11.88 • n=1581 Participants
|
43.3 years
STANDARD_DEVIATION 11.39 • n=4626 Participants
|
42.1 years
STANDARD_DEVIATION 11.48 • n=72 Participants
|
42.8 years
STANDARD_DEVIATION 11.72
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
29 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
21 Participants
n=72 Participants
|
77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
8 Participants
n=72 Participants
|
29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=41 Participants
|
22 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
23 Participants
n=72 Participants
|
77 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
37 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
9 Participants
n=41 Participants
|
22 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
19 Participants
n=72 Participants
|
64 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
2 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Randomization Day 1 to 84 days after randomizationPopulation: The Pharmacokinetic (PK) Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=29 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=28 Participants
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
|
29.68 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 50.13
|
39.26 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 45.10
|
35.62 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 67.55
|
PRIMARY outcome
Timeframe: Randomization Day 1 to 84 days after randomizationPopulation: The PK Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
n=30 Participants
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=27 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=26 Participants
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)
|
18461.94 hours*ng/mL
Geometric Coefficient of Variation 35.44
|
20994.08 hours*ng/mL
Geometric Coefficient of Variation 33.77
|
20185.90 hours*ng/mL
Geometric Coefficient of Variation 47.35
|
PRIMARY outcome
Timeframe: Randomization Day 1 to 84 days after randomizationPopulation: The PK Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
n=27 Participants
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=24 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=23 Participants
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)
|
19011.66 hours*ng/mL
Geometric Coefficient of Variation 37.21
|
21703.07 hours*ng/mL
Geometric Coefficient of Variation 35.06
|
22146.09 hours*ng/mL
Geometric Coefficient of Variation 42.77
|
SECONDARY outcome
Timeframe: Randomization Day 1 through Randomization Day 29Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations). This outcome measure reports data for the participants who received one of the Olanzapine SC extended-release formulations only.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A TEAE was defined as an AE that occurred after the first dose of study drug administration through the end of trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=29 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
|
9 Participants
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Randomization Day 1 through Randomization Day 29Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations). This outcome measure reports data for the participants who received one of the Olanzapine SC extended-release formulations only.
The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=29 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=31 Participants
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours after administration of ZYPREXA (Day 4)Population: The PK Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=97 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Cmax of ZYPREXA (Immediate-release Formulation)
|
—
|
11.09 ng/mL
Geometric Coefficient of Variation 82.89
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)Population: The PK Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=91 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
AUC0-t of ZYPREXA (Immediate-release Formulation)
|
—
|
264.22 hours*ng/mL
Geometric Coefficient of Variation 48.14
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)Population: The PK Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 3: Olanzapine (Slow-C)
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
Cohort 1: Olanzapine (Fast-D)
n=93 Participants
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|
|
Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)
|
—
|
0.0159 1/hour
Standard Deviation 0.00381
|
—
|
Adverse Events
ZYPREXA
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 1: Olanzapine (Fast-D)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: Olanzapine (To-be-marketed)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 3: Olanzapine (Slow-C)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZYPREXA
n=98 participants at risk
Participants received a single injection of 5 mg of ZYPREXA, immediate-release solution, administered IM to the gluteal muscle.
|
Cohort 1: Olanzapine (Fast-D)
n=29 participants at risk
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=31 participants at risk
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
Cohort 3: Olanzapine (Slow-C)
n=31 participants at risk
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/98 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/29 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/31 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
Other adverse events
| Measure |
ZYPREXA
n=98 participants at risk
Participants received a single injection of 5 mg of ZYPREXA, immediate-release solution, administered IM to the gluteal muscle.
|
Cohort 1: Olanzapine (Fast-D)
n=29 participants at risk
Participants received a single injection of 425 mg of olanzapine (Fast-D), extended-release formulation, administered SC to the abdomen.
|
Cohort 2: Olanzapine (To-be-marketed)
n=31 participants at risk
Participants received a single injection of 425 mg of olanzapine (To-be-marketed), extended-release formulation, administered SC to the abdomen.
|
Cohort 3: Olanzapine (Slow-C)
n=31 participants at risk
Participants received a single injection of 425 mg of olanzapine (Slow-C), extended-release formulation, administered SC to the abdomen.
|
|---|---|---|---|---|
|
General disorders
Injection site irritation
|
0.00%
0/98 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.9%
2/29 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/31 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
General disorders
Injection site pain
|
0.00%
0/98 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.9%
2/29 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
9.7%
3/31 • Number of events 3 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/31 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Infections and infestations
Urinary tract infection
|
5.1%
5/98 • Number of events 5 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/29 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.5%
2/31 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/31 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/98 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/29 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.5%
2/31 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/98 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/29 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.5%
2/31 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Investigations
Blood creatine phosphokinase increased
|
1.0%
1/98 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.4%
1/29 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.5%
2/31 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/31 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Nervous system disorders
Headache
|
6.1%
6/98 • Number of events 8 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/29 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
0.00%
0/31 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Nervous system disorders
Somnolence
|
5.1%
5/98 • Number of events 5 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.4%
1/29 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
9.7%
3/31 • Number of events 3 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.5%
2/31 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/98 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
6.9%
2/29 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 1 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
3.2%
1/31 • Number of events 2 • Day 1 up to Day 84
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations).
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D LLC
Phone: 888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER