Trial Outcomes & Findings for A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease (NCT NCT04971733)
NCT ID: NCT04971733
Last Updated: 2025-06-10
Results Overview
A TEAE was defined as adverse event (AE) that started at or after the time of administration of study drug or a worsening of severity from Baseline on or after 1st dose up to last assessment. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product. SAE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
From first dose of study drug up to 120 weeks
Results posted on
2025-06-10
Participant Flow
Participants took part in the study at 3 investigative sites in the United States and United Kingdom from 28 June 2021 and 24 May 2024.
The study was conducted in two cohorts (Cohort A \[Phase 1b and 2\] and Cohort B). A total of 11 participants were screened, of which 3 were screen failures and 8 were enrolled to receive study treatment.
Participant milestones
| Measure |
Cohort A: E2814
Participants received E2814 intravenous (IV) infusion, every 4 weeks (Q4W) at dose of 750 milligrams (mg) for 12 weeks, followed by 1500 mg for 12 weeks, further followed by 3000 mg for 12 weeks and then 4500 mg for up to 72 weeks.
|
Cohort B: E2814
Participants received E2814 3000 mg, IV infusion, Q4W for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
|
Overall Study
Cohort A: E2814 750 mg
|
7
|
0
|
|
Overall Study
Cohort A: E2814 1500 mg
|
7
|
0
|
|
Overall Study
Cohort A: E2814 3000 mg
|
7
|
0
|
|
Overall Study
Cohort A: E2814 4500 mg
|
4
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Cohort A: E2814
Participants received E2814 intravenous (IV) infusion, every 4 weeks (Q4W) at dose of 750 milligrams (mg) for 12 weeks, followed by 1500 mg for 12 weeks, further followed by 3000 mg for 12 weeks and then 4500 mg for up to 72 weeks.
|
Cohort B: E2814
Participants received E2814 3000 mg, IV infusion, Q4W for 52 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Subject choice
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Cohort A: E2814
n=7 Participants
Participants received E2814 IV infusion, Q4W at dose of 750 mg for 12 weeks, followed by 1500 mg for 12 weeks, further followed by 3000 mg for 12 weeks and then 4500 mg for up to 72 weeks.
|
Cohort B: E2814
n=1 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 52 weeks.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 120 weeksPopulation: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. As pre-specified in statistical analysis plan (SAP), the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
A TEAE was defined as adverse event (AE) that started at or after the time of administration of study drug or a worsening of severity from Baseline on or after 1st dose up to last assessment. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product. SAE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=8 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=4 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
4 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 120 weeksPopulation: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
Clinical laboratory tests included hematology, clinical chemistry, and urinalysis assessments. Markedly abnormal value was defined as a post-baseline value with an increase from baseline to a grade of 2 or higher on Common Terminology Criteria for Adverse events (CTCAE) Version 5.0 scale.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=8 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=4 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Laboratory Values
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 120 weeksPopulation: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
Vital sign measurements included systolic and diastolic blood pressure, pulse, respiratory rate, body temperature, height and weight assessment. The clinically significant assessment was based on investigator judgement.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=8 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=4 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Signs Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 120 weeksPopulation: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
The clinically significant assessment was based on investigator judgement.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=8 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=4 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose at Week 12Population: The Pharmacodynamic (PD) Analysis Set was the group of participants who received at least 1 dose of study drug and had sufficient PD data to derive at least 1 PD parameter. As planned, this outcome measure was assessed for E2814 750 mg only in Cohort A.
Total MTBR-Tau was the total of bound MTBR-Tau + free MTBR-Tau. CSF samples were collected for the assessment.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
Change in CSF Free MTBR-tau354
|
-0.0534 nanogram per milliliter (ng/mL)
Standard Deviation 0.0690
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
Change in CSF Free MTBR-tau299
|
-0.0147 nanogram per milliliter (ng/mL)
Standard Deviation 0.0267
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
Change in CSF Bound MTBR-tau354
|
0.178 nanogram per milliliter (ng/mL)
Standard Deviation 0.0886
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
Change in CSF Bound MTBR-tau299
|
0.0420 nanogram per milliliter (ng/mL)
Standard Deviation 0.0194
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
Change in CSF Total MTBR-tau354
|
0.125 nanogram per milliliter (ng/mL)
Standard Deviation 0.0899
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
Change in CSF Total MTBR-tau299
|
0.0273 nanogram per milliliter (ng/mL)
Standard Deviation 0.0191
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dosePopulation: The Pharmacokinetic (PK) Analysis Set was the group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. As planned, this PK parameter was assessed for E2814 750 mg and 1500 mg only in Cohort A.
The concentration of E2814 were measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A, Cmax: Maximum Observed Plasma Concentration for E2814
|
218 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 25.9
|
499 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 24.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dosePopulation: The PK Analysis Set was the group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. As planned, this PK parameter was assessed for E2814 750 mg and 1500 mg only in Cohort A.
The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A, Tmax: Time to Reach the Maximum Plasma Concentration for E2814
|
1.00 hours
Interval 1.0 to 5.0
|
1.00 hours
Interval 1.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dosePopulation: PK Analysis Set was group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. As planned, this PK parameter was assessed for E2814 750 mg and 1500 mg only in Cohort A. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure (sampling for first dose of 1500 mg was less intense versus the first dose of 750 mg; thus, no participants were evaluable for 1500 mg group for AUC\[0-672h\]).
The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A, AUC(0-672h): Area Under the Plasma Concentration-time Curve From Zero Time to 672 Hours for E2814
|
66500 hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 23.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dosePopulation: The PK Analysis Set was the group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. As planned, this PK parameter was assessed for E2814 750 mg and 1500 mg only in Cohort A.
The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A, Cmax: Maximum Observed Serum Concentration for E2814
|
41.7 mcg/mL
Geometric Coefficient of Variation 64.1
|
101 mcg/mL
Geometric Coefficient of Variation 47.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dosePopulation: The PK Analysis Set was the group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. As planned, this PK parameter was assessed for E2814 750 mg and 1500 mg only in Cohort A.
The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A, Tmax: Time to Reach the Maximum Serum Concentration for E2814
|
1.00 hours
Interval 1.0 to 25.0
|
5.00 hours
Interval 1.0 to 9.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dosePopulation: PK Analysis Set was group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. As planned, this PK parameter was assessed for E2814 750 mg and 1500 mg only in Cohort A. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure (sampling for first dose of 1500 mg was less intense versus the first dose of 750 mg; thus, no participants were evaluable for 1500 mg group for AUC\[0-672h\]).
The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A, AUC(0-672h): Area Under the Serum Concentration-time Curve From Zero Time to 672 Hours for E2814
|
8030 h*mcg/mL
Geometric Coefficient of Variation 54.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Days 1, 84, 85, 169, 253, 421, and 757Population: The PK Analysis Set was the group of participants who received at least 1 dose of test drug and had sufficient PK data to derive at least 1 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at given time points for specified dosing group.
The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=5 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=2 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A: CSF Concentrations of E2814
Day 1: Pre-dose
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
|
Cohort A: CSF Concentrations of E2814
Day 84: Pre-dose
|
172 ng/mL
Standard Deviation 77.8
|
—
|
—
|
—
|
|
Cohort A: CSF Concentrations of E2814
Day 85: Pre-dose
|
153 ng/mL
Standard Deviation 32.2
|
—
|
—
|
—
|
|
Cohort A: CSF Concentrations of E2814
Day 169: Pre-dose
|
—
|
429 ng/mL
Standard Deviation 212
|
—
|
—
|
|
Cohort A: CSF Concentrations of E2814
Day 253: Pre-dose
|
—
|
—
|
806 ng/mL
Standard Deviation 426
|
—
|
|
Cohort A: CSF Concentrations of E2814
Day 421: Pre-dose
|
—
|
—
|
1035 ng/mL
Standard Deviation 35.4
|
—
|
|
Cohort A: CSF Concentrations of E2814
Day 757: Pre-dose
|
—
|
—
|
—
|
1611 ng/mL
Standard Deviation 1567
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 120 weeksPopulation: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Anti-E2814 antibodies were measured by validated electrochemiluminescence assay.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=6 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=3 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Positive Serum Anti-E2814 Antibody
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 120 weeksPopulation: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Anti-E2814 antibodies were measured by validated electrochemiluminescence assay.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=7 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=6 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=3 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Positive Plasma Anti-E2814 Antibody
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757Population: The PD Analysis Set was the group of participants who received at least 1 dose of study drug and had sufficient PD data to derive at least 1 PD parameter. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at given time points for specified dosing group.
CSF samples were collected for the assessment.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=2 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=5 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=4 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=2 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 84: Pre-dose
|
-210 picogram per milliliter (pg/mL)
Standard Deviation 156
|
-139 picogram per milliliter (pg/mL)
Standard Deviation 53.5
|
—
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 169: Pre-dose
|
—
|
-151 picogram per milliliter (pg/mL)
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
-236 picogram per milliliter (pg/mL)
Standard Deviation 88.3
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 253: Pre-dose
|
—
|
—
|
-296 picogram per milliliter (pg/mL)
Standard Deviation 232
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 421: Pre-dose
|
—
|
—
|
-216 picogram per milliliter (pg/mL)
Standard Deviation 127
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 505: Pre-dose
|
—
|
—
|
—
|
-315 picogram per milliliter (pg/mL)
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 589: Pre-dose
|
—
|
—
|
—
|
-147 picogram per milliliter (pg/mL)
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243
Change at Day 757: Pre-dose
|
—
|
—
|
—
|
-381 picogram per milliliter (pg/mL)
Standard Deviation 377
|
SECONDARY outcome
Timeframe: Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757Population: The PD Analysis Set was the group of participants who received at least 1 dose of study drug and had sufficient PD data to derive at least 1 PD parameter. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at given time points for specified dosing group.
CSF samples were collected for the assessment.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=2 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=5 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=5 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=2 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 84: Predose
|
-166.50 pg/mL
Standard Deviation 33.177
|
2.41 pg/mL
Standard Deviation 204.061
|
—
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 169: Predose
|
—
|
-10.32 pg/mL
Standard Deviation 131.136
|
-249.82 pg/mL
Standard Deviation 351.972
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 253: Predose
|
—
|
—
|
-308.74 pg/mL
Standard Deviation 443.284
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 421: Predose
|
—
|
—
|
-84.85 pg/mL
Standard Deviation 106.021
|
-1032.26 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 505: Predose
|
—
|
—
|
—
|
-50.49 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 589: Predose
|
—
|
—
|
—
|
-106.21 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 181 at Day 757: Predose
|
—
|
—
|
—
|
-606.64 pg/mL
Standard Deviation 561.342
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 84: Predose
|
-38.37 pg/mL
Standard Deviation 26.736
|
-14.70 pg/mL
Standard Deviation 101.226
|
—
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 169: Predose
|
—
|
-67.43 pg/mL
Standard Deviation 126.128
|
-34.19 pg/mL
Standard Deviation 86.949
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 253: Predose
|
—
|
—
|
-84.42 pg/mL
Standard Deviation 71.648
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 421: Predose
|
—
|
—
|
-25.26 pg/mL
Standard Deviation 4.975
|
-113.91 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 505: Predose
|
—
|
—
|
—
|
-24.12 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 589: Predose
|
—
|
—
|
—
|
4.48 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 205 at Day 757: Predose
|
—
|
—
|
—
|
-73.59 pg/mL
Standard Deviation 58.215
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 84: Predose
|
-190.56 pg/mL
Standard Deviation 120.537
|
-216.52 pg/mL
Standard Deviation 258.741
|
—
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 169: Predose
|
—
|
-294.28 pg/mL
Standard Deviation 350.271
|
-188.49 pg/mL
Standard Deviation 47.791
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 253: Predose
|
—
|
—
|
-375.74 pg/mL
Standard Deviation 246.487
|
—
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 421: Predose
|
—
|
—
|
-217.44 pg/mL
Standard Deviation 134.880
|
-680.92 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 505: Predose
|
—
|
—
|
—
|
-368.02 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 589: Predose
|
—
|
—
|
—
|
-135.13 pg/mL
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217
Change in P-tau 217 at Day 757: Predose
|
—
|
—
|
—
|
-422.60 pg/mL
Standard Deviation 335.717
|
SECONDARY outcome
Timeframe: Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757Population: The PD Analysis Set was the group of participants who received at least 1 dose of study drug and had sufficient PD data to derive at least 1 PD parameter. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at given time points for specified dosing group.
CSF samples were collected for the assessment.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=2 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=5 Participants
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=5 Participants
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=2 Participants
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 505: Predose
|
—
|
—
|
—
|
-16.05 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 84: Predose
|
0.95 ratio
Standard Deviation 2.463
|
10.21 ratio
Standard Deviation 12.187
|
—
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 169: Predose
|
—
|
17.54 ratio
Standard Deviation 16.734
|
-8.88 ratio
Standard Deviation 15.713
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 253: Predose
|
—
|
—
|
2.96 ratio
Standard Deviation 12.693
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 421: Predose
|
—
|
—
|
3.23 ratio
Standard Deviation 4.146
|
-8.78 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 505: Predose
|
—
|
—
|
—
|
11.64 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 589: Predose
|
—
|
—
|
—
|
0.40 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau181/np-tau181 ratio at Day 757: Predose
|
—
|
—
|
—
|
-6.87 ratio
Standard Deviation 7.470
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 84: Predose
|
0.42 ratio
Standard Deviation 0.950
|
3.51 ratio
Standard Deviation 2.221
|
—
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 169: Predose
|
—
|
2.08 ratio
Standard Deviation 0.525
|
0.86 ratio
Standard Deviation 4.695
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 253: Predose
|
—
|
—
|
2.53 ratio
Standard Deviation 1.647
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 421: Predose
|
—
|
—
|
1.16 ratio
Standard Deviation 0.915
|
4.53 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 505: Predose
|
—
|
—
|
—
|
2.32 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 589: Predose
|
—
|
—
|
—
|
2.02 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau205/np-tau205 ratio at Day 757: Predose
|
—
|
—
|
—
|
1.80 ratio
Standard Deviation 0.035
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 84: Predose
|
-3.03 ratio
Standard Deviation 4.624
|
-5.49 ratio
Standard Deviation 4.240
|
—
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 169: Predose
|
—
|
-8.13 ratio
Standard Deviation 5.564
|
-8.48 ratio
Standard Deviation 6.258
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 253: Predose
|
—
|
—
|
-10.74 ratio
Standard Deviation 5.265
|
—
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 421: Predose
|
—
|
—
|
-10.16 ratio
Standard Deviation 4.143
|
-15.35 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 589: Predose
|
—
|
—
|
—
|
-8.52 ratio
Standard Deviation NA
Standard Deviation could not be calculated for single participant.
|
|
Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205
Change in P-tau217/np-tau217 ratio at Day 757: Predose
|
—
|
—
|
—
|
-14.56 ratio
Standard Deviation 5.138
|
SECONDARY outcome
Timeframe: Baseline, at Weeks 60 and 108Population: The PD Analysis Set was the group of participants who received at least 1 dose of study drug and had sufficient PD data to derive at least 1 PD parameter. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. As planned, this outcome measure was assessed for 4500 mg only in Cohort A.
Tau-PET imaging uses radiotracers to visualize tau protein deposits in the brain for regional assessment of tau pathology. SUVR is ratio of tracer uptake in each of the cingulate, frontal, medial, occipital, parietal, whole cortical, meta temporal, and temporal cortices relative to tracer uptake in the cerebellum.
Outcome measures
| Measure |
Cohort A: E2814 750 mg
n=3 Participants
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Cingulate Region at Week 60
|
0.135 SUVR
Standard Deviation 0.3756
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Cingulate Region at Week 108
|
0.296 SUVR
Standard Deviation 0.4628
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Frontal Region at Week 60
|
0.138 SUVR
Standard Deviation 1.0103
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Frontal Region at Week 108
|
0.159 SUVR
Standard Deviation 0.9609
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Medial Temporal Region at Week 60
|
0.165 SUVR
Standard Deviation 0.5615
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Medial Temporal Region at Week 108
|
0.071 SUVR
Standard Deviation 0.5421
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Occipital Region at Week 60
|
0.258 SUVR
Standard Deviation 0.9359
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Occipital Region at Week 108
|
0.320 SUVR
Standard Deviation 0.8409
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Parietal Region at Week 60
|
0.124 SUVR
Standard Deviation 0.9826
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Parietal Region at Week 108
|
0.017 SUVR
Standard Deviation 0.8415
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Temporal Region at Week 60
|
0.218 SUVR
Standard Deviation 0.9283
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Temporal Region at Week 108
|
0.093 SUVR
Standard Deviation 0.7699
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Meta-Temporal Region at Week 60
|
0.179 SUVR
Standard Deviation 0.9515
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Meta-Temporal Region at Week 108
|
0.014 SUVR
Standard Deviation 0.7942
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Whole Cortical Gray Matter (GM) Region at Week 60
|
0.172 SUVR
Standard Deviation 0.9461
|
—
|
—
|
—
|
|
Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region
Change in PET tau SUVR in Whole Cortical GM Region at Week 108
|
0.133 SUVR
Standard Deviation 0.8421
|
—
|
—
|
—
|
Adverse Events
Cohort A: E2814 750 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort A: E2814 1500 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A+B: E2814 3000 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort A: E2814 4500 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: E2814 750 mg
n=7 participants at risk
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 participants at risk
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=8 participants at risk
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=4 participants at risk
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
Other adverse events
| Measure |
Cohort A: E2814 750 mg
n=7 participants at risk
Participants received E2814 750 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A: E2814 1500 mg
n=7 participants at risk
Participants received E2814 1500 mg, IV infusion, Q4W for 12 weeks.
|
Cohort A+B: E2814 3000 mg
n=8 participants at risk
Participants received E2814 3000 mg, IV infusion, Q4W for 12 weeks in Cohort A and for 52 weeks in Cohort B.
|
Cohort A: E2814 4500 mg
n=4 participants at risk
Participants received E2814 4500 mg, IV infusion, Q4W for up to 72 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
COVID-19
|
28.6%
2/7 • Number of events 2 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Otitis media
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
50.0%
2/4 • Number of events 2 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia recurrent
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Bradykinesia
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 2 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Hemiapraxia
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 2 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Chronic pigmented purpura
|
14.3%
1/7 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/7 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/8 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
0.00%
0/4 • From first dose of study drug up to 120 weeks
As pre-specified in SAP, the data of Cohort B was combined with Cohort A for E2814 3000 mg group due to same dosing in both cohorts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place