Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Period 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 Up to Day 43	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. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all serious AEs (SAEs), regardless of causality is located in the Reported AE section.
Primary	Period 2: Number of Participants With Treatment Emergent SAEs	Day 1 Up to Day 43	An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. 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. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section.
Primary	Period 2: Number of Participants With Injection Site AEs	Day 1 Up to Day 43	Injection site AEs included injection site pruritus, induration, warmth, and abscess. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section. All injection site AEs are reported in this outcome measure and the AE module only reports non-serious AEs at the 5% threshold. In the AE module, a participant could have been included for multiple injection site AEs.
Secondary	Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749	Day 1 Up to Day 43
Secondary	Period 2: Area Under the Plasma Drug Concentration-time Curve (AUC) Over the Period Following Administration on Day 1 to the Time of the Last Measurable Concentration (AUC0-t) of TV-44749	Day 1 Up to Day 43
Secondary	Period 2: AUC of TV-44749 Over the Period Following Administration on Day 1 Extrapolated to Infinity (AUC0-inf)	Day 1 Up to Day 43
Secondary	Period 2: Time to Maximum Observed Concentration (Tmax) of TV-44749	Day 1 Up to Day 43
Secondary	Period 2: Apparent Elimination Half-Life (t½) of TV-44749	Day 1 Up to Day 43
Secondary	Period 1: Maximum Observed Plasma Drug Concentration at Steady State (Cmax,ss[Oral Olanzapine])	Day -8
Secondary	Period 1: AUC of Oral Olanzapine From Time 0 to the End of the Dosing Interval (24 Hour) at Steady State (AUC0-tau,ss[Oral Olanzapine])	Day -8
Secondary	Period 1: Calculated AUC of Oral Olanzapine at Steady State Extrapolated Over 28 Days (AUC0-tau,ss[Oral Olanzapine] * 28)	Day -8 up to Day 20	The steady-state AUC of oral olanzapine over a 28-day dosing interval was calculated by extrapolating the 24-hour AUC obtained following administration of the seventh oral dose (Day -8) to a 28-day period (AUC0-tau,ss\[oral olanzapine\] \* 28).
Secondary	Period 1: Time to Maximum Concentration of Oral Olanzapine at Steady State (Tmax,ss[Oral Olanzapine])	Day -8
Secondary	Period 1: Number of Participants With TEAEs	Day -14 up to Day -8	An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section.
Secondary	Period 1: Number of Participants With Treatment Emergent SAEs	Day -14 up to Day -8	An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. 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. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-SAEs and all serious AEs, regardless of causality is located in the Reported AE section.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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