Trial Outcomes & Findings for A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease (NCT NCT05476783)
NCT ID: NCT05476783
Last Updated: 2026-05-06
Results Overview
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale with 0: no suicidal behavior and 5: active suicidal ideation. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25). Higher scores in the scale indicate greater disease severity. An increase from baseline in the total score of C-SSRS \>=1 is considered as an adverse change.
TERMINATED
PHASE2
119 participants
Baseline and up to 61 weeks
2026-05-06
Participant Flow
This study enrolled adult patients who completed the lead-in Protocol TB006AD2102 (patients from both TB006 treatment and placebo groups) or were eligible for the lead-in study but were not enrolled (de novo). A total of 125 patients were screened, of whom 6 (4.8%) patients were screening failures, 119 patients were included in the study. Study Period: Approximately 14 Months Date of First Enrollment: 15 Sep 2022 Date of Last Completed: 17 Nov 2023 Multicenter, 15 sites in the US.
Participant milestones
| Measure |
TB006 4000 mg
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
119
|
Reasons for withdrawal
| Measure |
TB006 4000 mg
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Overall Study
This was a business decision, and not due to safety or efficacy concerns
|
108
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Other, not specified
|
1
|
Baseline Characteristics
A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 8.1 • n=54 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=54 Participants
|
|
Diagnosis of Alzheimers Disease
|
119 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Up to 61 weeksPopulation: All enrolled patients
Summary for Number of Participants with Adverse Events and Serious Adverse Events
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Adverse Events
|
58 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
No Adverse Events
|
61 Participants
|
PRIMARY outcome
Timeframe: Up to 61 weeksPopulation: All enrolled patients
Summary of participants with Clinically Significant Clinical Laboratory Parameter Values
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Number of Participants With Clinically Significant Clinical Laboratory Parameter Values
Clinically Significant Labs Reported
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Laboratory Parameter Values
No Clinically Significant Labs Reported
|
119 Participants
|
PRIMARY outcome
Timeframe: Up to 61 weeksPopulation: All enrolled patients
Summary of Participants with Clinically Significant Vital Sign Values
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Number of Participants With Clinically Significant Vital Sign Values
Significant (meaningful) Vital Sign Changes
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Values
No Significant (meaningful) Vital Sign Changes
|
119 Participants
|
PRIMARY outcome
Timeframe: Up to 61 weeksPopulation: All enrolled patients
Summary of Participants with Clinically Significant 12-Lead electrocardiogram Findings
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Findings
Clinically Significant (meaningful) 12-Lead electrocardiogram Changes
|
0 Participants
|
|
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Findings
No Clinically Significant (meaningful) 12-Lead electrocardiogram Changes
|
119 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 61 weeksPopulation: All enrolled patients
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale with 0: no suicidal behavior and 5: active suicidal ideation. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25). Higher scores in the scale indicate greater disease severity. An increase from baseline in the total score of C-SSRS \>=1 is considered as an adverse change.
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Number of patients with an adverse change from baseline in C-SSRS
|
1 Participants
|
|
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Number of patients with no change from baseline in C-SSRS
|
118 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, and Weeks 1, 5, 9, 13, 17, 21, 25, 45, 73, 101, 113 and ED/EOS up to Week 61Population: Due to early termination, no participants completed the trial through Week 113. Sites were notified of termination before any scheduled Week 45 visits occurred. Thus, scheduled samples for Weeks 45, 73, 101, and 113 were cancelled and not collected. All active participants instead completed an End of Study (EOS) visit. While some EOS close-out visits occurred up to Week 61 chronologically, all data are strictly reported as EOS. There are no plans for future analysis.
Summary of plasma concentration of TB006
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Plasma Concentration of TB006
Week 1 PK concentration
|
70.97 μg/mL
Standard Deviation 288.97
|
|
Plasma Concentration of TB006
Week 5 PK concentration
|
412.91 μg/mL
Standard Deviation 131.78
|
|
Plasma Concentration of TB006
Week 9 PK concentration
|
615.86 μg/mL
Standard Deviation 257.17
|
|
Plasma Concentration of TB006
Week 13 PK concentration
|
694.85 μg/mL
Standard Deviation 334.03
|
|
Plasma Concentration of TB006
Week 17 PK concentration
|
733.19 μg/mL
Standard Deviation 298.13
|
|
Plasma Concentration of TB006
Week 21 PK concentration
|
791.79 μg/mL
Standard Deviation 313.83
|
|
Plasma Concentration of TB006
Week 25 PK concentration
|
852.00 μg/mL
Standard Deviation 389.09
|
|
Plasma Concentration of TB006
ED/EOS PK concentration
|
382.56 μg/mL
Standard Deviation 366.55
|
PRIMARY outcome
Timeframe: Up to 61 weeksPopulation: All enrolled patients
Summary of Participants with Anti-TB006 Antibodies
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Number of Participants With Anti-TB006 Antibodies
ADA positive at end of study; No evidence of an altered safety profile in positive patients.
|
9 Participants
|
|
Number of Participants With Anti-TB006 Antibodies
ADA negative patients at end of study
|
110 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 101Population: The study has terminated prior to week 101. The last CDR-SB was analyzed for each individual participant at their end of study, up to week 61.
The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR SB) Score
|
0.12 units on a scale
Standard Deviation 1.606
|
SECONDARY outcome
Timeframe: Baseline and up to Week 101Population: The study has terminated prior to week 101. The last MMSE was analyzed for each individual participant at their end of study, up to week 61.
Global cognitive functioning is measured by MMSE. MMSE is a neuropsychological test for the evaluation of intellectual efficiency disorders and the presence of cognitive impairment. The total score is between a minimum of 0 (worse cognitive function) and a maximum of 30 points (normal cognitive function). A lower score indicates severe impairment of cognitive abilities and a higher score indicates cognitive normality.
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score
|
-0.9 units on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Baseline and up to Week 101Population: The study has terminated prior to week 101. The last NPI was analyzed for each individual participant at their end of study, up to week 61.
The NPI is a condition-specific measure designed to assess 12 behavioral disturbances, namely delusions, hallucinations, depression/dysphoria, anxiety, agitation/aggression, elation/euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite/eating abnormalities. The frequency is scored from 0 (never) to 4 (very frequently) and severity ranges between 0 (none) to 3 (marked). The domain score is obtained by multiplying frequency and severity scores. The total NPI score is the sum total of all individual domain scores (0-144). A higher score indicates abnormal behaviour.
Outcome measures
| Measure |
TB006 4000 mg
n=119 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Change From Baseline in Neuropsychiatry Inventory (NPI) Score
|
1.4 units on a scale
Standard Deviation 13.44
|
SECONDARY outcome
Timeframe: Baseline and up to Week 101Population: The study has terminated prior to week 101. The last EuroQol 5 Dimension 5-Level was analyzed for each individual participant and separately by the caregiver at the end of study, up to week 61. The Overall Number of Participants Analyzed represents the sum of patient participants and caregivers assessed. Caregivers were not considered enrolled.
EuroQol 5 is a self-reported description of participant's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants to grade their own current level of function in each dimension into one of three degrees of disability (severe, moderate or none). Score ranges between 1 (no problem) and 3 (significant problem). higher scores indicating higher health utility. The total score is the sum total of all individual domain scores (5-15). Higher scores indicates poor quality of life.
Outcome measures
| Measure |
TB006 4000 mg
n=167 Participants
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5-Level Quality of Life (EQ 5D 5L QoL) Total Score
For Patient
|
2.1 units on a scale
Standard Deviation 13.06
|
|
Change From Baseline in EuroQol 5 Dimension 5-Level Quality of Life (EQ 5D 5L QoL) Total Score
For Caregiver
|
2.2 units on a scale
Standard Deviation 17.72
|
Adverse Events
TB006 4000 mg
Serious adverse events
| Measure |
TB006 4000 mg
n=119 participants at risk
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Cardiac disorders
Atrial flutter
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
General disorders
Asthenia
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Infections and infestations
Influenza
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Infections and infestations
Rhinovirus infection
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Nervous system disorders
Encephalopathy
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Nervous system disorders
Syncope
|
0.84%
1/119 • Number of events 1 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
Other adverse events
| Measure |
TB006 4000 mg
n=119 participants at risk
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
TB006: Clear to slightly opalescent, sterile solution for injection
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
5.9%
7/119 • Number of events 7 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Infections and infestations
COVID-19
|
5.0%
6/119 • Number of events 6 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
3/119 • Number of events 3 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
7/119 • Number of events 7 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Investigations
Blood pressure increased
|
4.2%
5/119 • Number of events 5 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Nervous system disorders
Syncope
|
2.5%
3/119 • Number of events 3 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Psychiatric disorders
Agitation
|
2.5%
3/119 • Number of events 4 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
|
Psychiatric disorders
Depression
|
2.5%
3/119 • Number of events 3 • All Adverse Events (AEs) were collected from the time of the first study drug administration until Week 61 at the time points specified in the Schedule of Events.
Any adverse event (AE) ongoing at the start of open-label extension (OLE) dosing, including those from the initial visit, was counted as an AE. Events reported after the first study drug dose were classified as treatment-emergent AEs (TEAEs). Patients with multiple AEs in a system organ class or by Preferred Term were counted once. Medical events occurring after informed consent but before the study intervention were noted as medical history/current conditions, not as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place