Trial Outcomes & Findings for Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease (NCT NCT04994483)
NCT ID: NCT04994483
Last Updated: 2025-05-25
Results Overview
The change from baseline to Week 52 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
804 participants
Primary outcome timeframe
Baseline (Study Day 1) to Week 52
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Simufilam 100 mg
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
403
|
401
|
|
Overall Study
COMPLETED
|
310
|
325
|
|
Overall Study
NOT COMPLETED
|
93
|
76
|
Reasons for withdrawal
| Measure |
Simufilam 100 mg
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
26
|
17
|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
|
Overall Study
Noncompliance with study drug
|
8
|
5
|
|
Overall Study
Physician Decision
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
41
|
38
|
|
Overall Study
Sponsor requests subject to be withdrawn
|
2
|
1
|
|
Overall Study
Met stopping criteria
|
1
|
0
|
|
Overall Study
Randomized in error, not treated
|
4
|
3
|
|
Overall Study
Lack of a reliable study partner
|
0
|
1
|
|
Overall Study
Met MRI exclusion criteria
|
0
|
1
|
Baseline Characteristics
Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Simufilam 100 mg
n=403 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=401 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
Total
n=804 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.72 years
STANDARD_DEVIATION 7.911 • n=5 Participants
|
74.31 years
STANDARD_DEVIATION 7.555 • n=7 Participants
|
74.02 years
STANDARD_DEVIATION 7.737 • n=5 Participants
|
|
Age, Customized
<65 years
|
62 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Customized
65 to 74 years
|
126 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Age, Customized
≥75 years
|
215 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
225 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
447 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
334 Participants
n=5 Participants
|
341 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
366 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
742 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
31 participants
n=5 Participants
|
21 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
336 participants
n=5 Participants
|
355 participants
n=7 Participants
|
691 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
36 participants
n=5 Participants
|
25 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).
Outcome measures
| Measure |
Simufilam 100 mg
n=306 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=320 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
|
2.79 score on a scale
Standard Error 0.363
|
3.19 score on a scale
Standard Error 0.359
|
PRIMARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the ADCS-ADL, a 23-item study partner questionnaire that covers both basic activities of daily living (ADL) and more complex ADL or instrumental ADL. Scores range from 0 to 78, with a lower score indicating greater severity of functional loss.
Outcome measures
| Measure |
Simufilam 100 mg
n=306 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=320 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
|
-3.26 score on a scale
Standard Error 0.442
|
-3.76 score on a scale
Standard Error 0.438
|
SECONDARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.
Outcome measures
| Measure |
Simufilam 100 mg
n=302 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=317 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS)
|
-5.53 score on a scale
Standard Error 0.605
|
-6.49 score on a scale
Standard Error 0.598
|
SECONDARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the NPI, a 12-item study partner interview, which records the frequency and severity of common neuropsychiatric symptoms in dementia, as well as the level of study partner distress due to each of the neuropsychiatric problems. Scores range from 0 to 144, with higher scores indicating more frequent and severe symptoms, and greater levels of partner distress.
Outcome measures
| Measure |
Simufilam 100 mg
n=301 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=316 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the Neuropsychiatric Inventory (NPI)
|
0.54 score on a scale
Standard Error 0.588
|
0.90 score on a scale
Standard Error 0.579
|
SECONDARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the MMSE, a set of standardized questions covering several target areas: orientation, registration, attention and calculation, short-term verbal recall, naming, repetition, 3-step command, reading, writing, and visuospatial cognitive assessment. Scores range from 0 to 30, lower scores indicate more severe impairment.
Outcome measures
| Measure |
Simufilam 100 mg
n=309 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=324 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the Mini-Mental State Exam (MMSE)
|
-1.95 score on a scale
Standard Error 0.223
|
-2.14 score on a scale
Standard Error 0.221
|
SECONDARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the CDR-SB, which characterizes 6 domains of cognitive and functional performance applicable to AD and related dementias: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores for each domain have a minimum of 0 and a maximum of 3, and the 6 domain scores are summed to give the CDR-SB, which has a minimum score of 0 and a maximum score of 18. Higher scores indicate more severe impairment.
Outcome measures
| Measure |
Simufilam 100 mg
n=334 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=339 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
|
1.04 score on a scale
Standard Error 0.138
|
0.85 score on a scale
Standard Error 0.136
|
SECONDARY outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Data are from subjects in the Intent-to-treat population (all randomized subjects) who completed the assessment.
The change from baseline to Week 52 in the ZBI, a 22-item study partner questionnaire designed to assess the stress or burden experienced by caregivers of people with dementia. Scores range from 0 to 88, with a higher score indicating greater stress or burden.
Outcome measures
| Measure |
Simufilam 100 mg
n=308 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=321 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Change From Baseline in the Zarit Burden Interview (ZBI)
|
2.52 score on a scale
Standard Error 0.556
|
2.30 score on a scale
Standard Error 0.551
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: The overall number of participants analyzed is the number of participants who consented to take part in the biomarker analysis substudy and for whom there were baseline values for each biomarker. Plasma samples were not obtained from the whole substudy population at Week 52.
Change from baseline in the following plasma biomarkers of AD pathology, neurodegeneration, and neuroinflammation: phospho-tau217 (P-tau217), glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and total tau.
Outcome measures
| Measure |
Simufilam 100 mg
n=57 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=62 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Changes From Baseline in Plasma Biomarkers
P-tau217
|
1.0 pg/mL
Standard Deviation 6.56
|
-0.4 pg/mL
Standard Deviation 9.77
|
|
Changes From Baseline in Plasma Biomarkers
GFAP
|
2.0 pg/mL
Standard Deviation 57.39
|
40.2 pg/mL
Standard Deviation 255.14
|
|
Changes From Baseline in Plasma Biomarkers
NfL
|
69.3 pg/mL
Standard Deviation 373.43
|
17.5 pg/mL
Standard Deviation 96.73
|
|
Changes From Baseline in Plasma Biomarkers
Total tau
|
5.5 pg/mL
Standard Deviation 35.62
|
-2.2 pg/mL
Standard Deviation 41.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Study Day 1) to Week 52Population: Change from baseline in SavaDx, a novel plasma biomarker, was included in the protocol as part of the secondary analysis as a biomarker which may have been measured. The final SAP, which postdated the protocol, included the analysis of biomarkers as an exploratory/tertiary endpoint. However, analysis of SavaDx was not conducted due to a sponsor decision and therefore, no results are available.
Change from baseline in SavaDx, a novel plasma biomarker
Outcome measures
Outcome data not reported
Adverse Events
Simufilam 100 mg
Serious events: 52 serious events
Other events: 161 other events
Deaths: 1 deaths
Placebo
Serious events: 36 serious events
Other events: 140 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Simufilam 100 mg
n=399 participants at risk
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=398 participants at risk
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.8%
7/399 • Number of events 7 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.50%
2/399 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.50%
2/398 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
1.0%
4/399 • Number of events 4 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.50%
2/398 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.50%
2/398 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.50%
2/398 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hyponatraemic encephalopathy
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Partial seizures
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Thalamic infarction
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
2/399 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.75%
3/398 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.75%
3/399 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.50%
2/399 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.50%
2/398 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.50%
2/399 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Norovirus infection
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.75%
3/399 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus arrest
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomach mass
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the bladder
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
1.0%
4/399 • Number of events 4 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.50%
2/399 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Aggression
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Paranoia
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
2/399 • Number of events 2 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.50%
2/398 • Number of events 3 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus decreased
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Investigations
Magnetic resonance imaging hepatobiliary abnormal
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Eye disorders
Amaurosis fugax
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Internal haemorrhage
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
1/399 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.00%
0/398 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/399 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Simufilam 100 mg
n=399 participants at risk
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Simufilam: Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
|
Placebo
n=398 participants at risk
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Placebo: Matching placebo given b.i.d. for 52 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
7.3%
29/399 • Number of events 29 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
8.8%
35/398 • Number of events 36 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
29/399 • Number of events 34 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
6.8%
27/398 • Number of events 35 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
11/399 • Number of events 13 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.0%
8/398 • Number of events 8 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
4.5%
18/399 • Number of events 19 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.8%
11/398 • Number of events 14 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.3%
21/399 • Number of events 23 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
0.25%
1/398 • Number of events 1 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
30/399 • Number of events 38 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
7.0%
28/398 • Number of events 35 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
16/399 • Number of events 17 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
4.0%
16/398 • Number of events 16 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
11/399 • Number of events 12 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.0%
8/398 • Number of events 8 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
10/399 • Number of events 11 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
1.3%
5/398 • Number of events 5 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
1.5%
6/399 • Number of events 6 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.5%
10/398 • Number of events 10 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.5%
14/399 • Number of events 14 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.3%
9/398 • Number of events 11 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
2.5%
10/399 • Number of events 10 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.8%
11/398 • Number of events 11 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
2.3%
9/399 • Number of events 9 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
1.3%
5/398 • Number of events 5 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
2.8%
11/399 • Number of events 11 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
2.8%
11/398 • Number of events 11 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.0%
8/399 • Number of events 8 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
1.3%
5/398 • Number of events 5 • Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.
Data are from the safety population, which included all subjects who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and PI must request review and comment of any proposed publication by the sponsor at least 90 days prior to submission of the publication. The sponsor will advise of any information which is confidential information or which may impair the sponsor's ability to obtain patent protection, and has the right to require confidential information or factual errors to be removed, or to delay the proposed publication by an additional 90 days to allow the sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER