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Trial Outcomes & Findings for Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease (NCT NCT05026177)

NCT ID: NCT05026177

Last Updated: 2025-09-22

Results Overview

The change from baseline to Week 76 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

TERMINATED

Study phase

PHASE3

Target enrollment

1125 participants

Primary outcome timeframe

Baseline (Study Day 1) to Week 76

Results posted on

2025-09-22

Participant Flow

Participation in the study required each subject to have a study partner who also consented to participate for the duration of the subject's participation. Study partners were not considered independent participants. The enrollment number and number of participants detailed below represents the number of subject/study partner dyads.

Participant milestones

Participant milestones
Measure
Simufilam 50 mg
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Overall Study
STARTED
376
374
375
Overall Study
Modified Intent-to-treat Population
299
311
308
Overall Study
Safety Population
376
374
373
Overall Study
MRI Imaging Substudy Population
76
66
72
Overall Study
Amyloid PET Imaging Substudy Population
43
28
35
Overall Study
Tau PET Imaging Substudy Population
98
65
96
Overall Study
Plasma Biomarker Analysis Substudy Population
98
65
96
Overall Study
CSF Biomarker Analysis Substudy Population
51
45
43
Overall Study
COMPLETED
201
203
217
Overall Study
NOT COMPLETED
175
171
158

Reasons for withdrawal

Reasons for withdrawal
Measure
Simufilam 50 mg
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Overall Study
Adverse Event
33
33
17
Overall Study
Lost to Follow-up
7
6
8
Overall Study
Noncompliance with study drug
6
2
1
Overall Study
Physician Decision
4
1
0
Overall Study
Sponsor requests subject to be withdrawn
0
0
3
Overall Study
Withdrawal by Subject
53
51
55
Overall Study
Protocol Violation
0
1
0
Overall Study
Study terminated by sponsor
70
74
67
Overall Study
Unavailability/noncompliance of study partner
2
1
1
Overall Study
Starting alternative treatment
0
1
1
Overall Study
Noncompliance with study procedures
0
1
1
Overall Study
Met stopping criteria
0
0
1
Overall Study
Health issues preventing continuation
0
0
1
Overall Study
Randomized in error, not treated
0
0
2

Baseline Characteristics

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Simufilam 50 mg
n=376 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=374 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=375 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Total
n=1125 Participants
Total of all reporting groups
Region of Enrollment
Puerto Rico
6 participants
n=99 Participants
9 participants
n=107 Participants
4 participants
n=206 Participants
19 participants
n=7 Participants
Age, Continuous
74.45 years
STANDARD_DEVIATION 7.624 • n=99 Participants
73.64 years
STANDARD_DEVIATION 8.185 • n=107 Participants
73.72 years
STANDARD_DEVIATION 7.926 • n=206 Participants
73.94 years
STANDARD_DEVIATION 7.916 • n=7 Participants
Age, Customized
<65 years
47 Participants
n=99 Participants
54 Participants
n=107 Participants
50 Participants
n=206 Participants
151 Participants
n=7 Participants
Age, Customized
65 to 74 years
115 Participants
n=99 Participants
124 Participants
n=107 Participants
131 Participants
n=206 Participants
370 Participants
n=7 Participants
Age, Customized
≥75 years
214 Participants
n=99 Participants
196 Participants
n=107 Participants
194 Participants
n=206 Participants
604 Participants
n=7 Participants
Sex: Female, Male
Female
207 Participants
n=99 Participants
208 Participants
n=107 Participants
214 Participants
n=206 Participants
629 Participants
n=7 Participants
Sex: Female, Male
Male
169 Participants
n=99 Participants
166 Participants
n=107 Participants
161 Participants
n=206 Participants
496 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
27 Participants
n=99 Participants
35 Participants
n=107 Participants
20 Participants
n=206 Participants
82 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
345 Participants
n=99 Participants
338 Participants
n=107 Participants
350 Participants
n=206 Participants
1033 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=99 Participants
1 Participants
n=107 Participants
5 Participants
n=206 Participants
10 Participants
n=7 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
4 Participants
n=7 Participants
Race/Ethnicity, Customized
Asian
21 Participants
n=99 Participants
28 Participants
n=107 Participants
32 Participants
n=206 Participants
81 Participants
n=7 Participants
Race/Ethnicity, Customized
Black or African American
23 Participants
n=99 Participants
17 Participants
n=107 Participants
21 Participants
n=206 Participants
61 Participants
n=7 Participants
Race/Ethnicity, Customized
White
326 Participants
n=99 Participants
326 Participants
n=107 Participants
313 Participants
n=206 Participants
965 Participants
n=7 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
6 Participants
n=7 Participants
Race/Ethnicity, Customized
Multiple
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Race/Ethnicity, Customized
Not reported
4 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
6 Participants
n=7 Participants
Race/Ethnicity, Customized
Unknown
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
Region of Enrollment
Canada
46 participants
n=99 Participants
47 participants
n=107 Participants
56 participants
n=206 Participants
149 participants
n=7 Participants
Region of Enrollment
South Korea
12 participants
n=99 Participants
18 participants
n=107 Participants
21 participants
n=206 Participants
51 participants
n=7 Participants
Region of Enrollment
United States
312 participants
n=99 Participants
300 participants
n=107 Participants
294 participants
n=206 Participants
906 participants
n=7 Participants

PRIMARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) who completed the assessment. No data were collected from study partners for this outcome measure.

The change from baseline to Week 76 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

Outcome measures
Measure
Simufilam 50 mg
n=167 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=181 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=188 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
5.71 score on a scale
Standard Error 0.529
5.65 score on a scale
Standard Error 0.509
5.26 score on a scale
Standard Error 0.506

PRIMARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) whose study partner completed the assessment.

The change from baseline to Week 76 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 for the subject. Scores range from 0 to 78, with a lower score indicating greater severity of functional loss.

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=169 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=179 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=187 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
-7.20 score on a scale
Standard Error 0.646
-6.87 score on a scale
Standard Error 0.623
-5.63 score on a scale
Standard Error 0.620

SECONDARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) who completed the assessment. No data were collected from study partners for this outcome measure.

The change from baseline to Week 76 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=167 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=177 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=185 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS)
-11.5 score on a scale
Standard Error 0.901
-11.5 score on a scale
Standard Error 0.870
-10.5 score on a scale
Standard Error 0.865

SECONDARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) whose study partner completed the assessment.

The change from baseline to Week 76 in the NPI, a 12-item study partner interview, which records the frequency and severity of common neuropsychiatric symptoms in dementia for the subject, as well as the level of study partner distress due to 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

Outcome measures
Measure
Simufilam 50 mg
n=176 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=191 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=199 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the Neuropsychiatric Inventory (NPI)
1.57 score on a scale
Standard Error 0.574
1.44 score on a scale
Standard Error 0.556
0.37 score on a scale
Standard Error 0.551

SECONDARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) who completed the assessment. No data were collected from study partners for this outcome measure.

The change from baseline to Week 76 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

Outcome measures
Measure
Simufilam 50 mg
n=179 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=197 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=206 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the MMSE
-3.48 score on a scale
Standard Error 0.288
-3.29 score on a scale
Standard Error 0.277
-3.35 score on a scale
Standard Error 0.275

SECONDARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) who completed the assessment. No data were collected from study partners for this outcome measure.

The change from baseline to Week 76 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

Outcome measures
Measure
Simufilam 50 mg
n=204 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=228 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=225 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
1.65 score on a scale
Standard Error 0.186
1.76 score on a scale
Standard Error 0.187
1.84 score on a scale
Standard Error 0.186

SECONDARY outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: Data are from the study partners of subjects in the modified intent-to-treat population (all randomized subjects with baseline plasma P-tau181 ≥44 pg/mL or other evidence of amyloid pathology, e.g., amyloid PET) who completed the assessment. No data were collected from study partners for this outcome measure.

The change from baseline to Week 76 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

Outcome measures
Measure
Simufilam 50 mg
n=169 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=180 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=185 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Change From Baseline in the Zarit Burden Interview (ZBI)
3.37 score on a scale
Standard Error 0.734
4.68 score on a scale
Standard Error 0.711
4.40 score on a scale
Standard Error 0.706

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: The overall number of subjects analyzed is the number of subjects who consented to take part in the MRI imaging substudy and for whom there was at least one non-missing post baseline MRI assessment available. MRIs were not conducted in the whole substudy population at Week 76. No data were collected from study partners for this outcome measure.

Changes from baseline in hippocampus, ventricles, and whole brain volume.

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=52 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=48 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=50 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Changes From Baseline in Brain Volume Via MRI
Whole brain volume
-17799.5 µL
Standard Deviation 13360.83
-19043.6 µL
Standard Deviation 9721.20
-17878.6 µL
Standard Deviation 14012.40
Changes From Baseline in Brain Volume Via MRI
Ventricular volume
5459.5 µL
Standard Deviation 4290.67
6109.9 µL
Standard Deviation 3766.34
6255.1 µL
Standard Deviation 5374.61
Changes From Baseline in Brain Volume Via MRI
Hippocampal volume
-180.7 µL
Standard Deviation 109.82
-192.2 µL
Standard Deviation 110.23
-186.8 µL
Standard Deviation 114.54

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: The overall number of subjects analyzed is the number of subjects who consented to take part in the amyloid PET imaging substudy and for whom there were baseline and Week 76 values. No data were collected from study partners for this outcome measure.

Changes from baseline in amyloid deposition in the brain.

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=31 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=19 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=27 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Changes From Baseline in Amyloid Positron Emission Tomography (PET)
0.0 µL
Standard Deviation 0.10
0.0 µL
Standard Deviation 0.09
0.0 µL
Standard Deviation 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: The overall number of subjects analyzed is the number of subjects who consented to take part in the tau PET imaging substudy and for whom there were baseline and Week 76 values. No data were collected from study partners for this outcome measure.

Changes from baseline in tau deposition in the brain

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=27 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=14 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=23 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Changes From Baseline in Tau Positron Emission Tomography (PET)
0.0 µL
Standard Error 0.10
0.0 µL
Standard Error 0.07
0.0 µL
Standard Error 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: The overall number of subjects analyzed is the number of subjects who consented to take part in the plasma biomarker analysis substudy and for whom there were baseline and Week 76 values for each biomarker. Plasma samples were not obtained from the whole substudy population at Week 76. No data were collected from study partners for this outcome measure.

Change from baseline in the following plasma biomarkers of AD pathology, neurodegeneration, and neuroinflammation: phospho-tau217 (P-tau217), total tau, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL).

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=47 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=27 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=41 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Changes From Baseline in Plasma Biomarkers
Plasma P-Tau 217
43.6 pg/mL
Standard Deviation 121.06
4.7 pg/mL
Standard Deviation 15.74
4.0 pg/mL
Standard Deviation 12.36
Changes From Baseline in Plasma Biomarkers
Plasma Total Tau
50.7 pg/mL
Standard Deviation 122.51
10.9 pg/mL
Standard Deviation 41.92
7.0 pg/mL
Standard Deviation 39.44
Changes From Baseline in Plasma Biomarkers
Plasma GFAP
636.5 pg/mL
Standard Deviation 1591.37
235.7 pg/mL
Standard Deviation 846.47
107.7 pg/mL
Standard Deviation 507.17
Changes From Baseline in Plasma Biomarkers
Plasma NfL
872.3 pg/mL
Standard Deviation 2023.12
321.3 pg/mL
Standard Deviation 1397.74
351.4 pg/mL
Standard Deviation 2075.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: The overall number of subjects analyzed is the number of subjects who consented to take part in the CSF biomarker analysis substudy and for whom there were baseline and Week 76 values for each biomarker. CSF samples were not obtained from the whole substudy population at Week 76. No data were collected from study partners for this outcome measure.

Changes from baseline in CSF biomarkers of AD pathology, neurodegeneration, and neuroinflammation: P-tau217, total tau, GFAP, and NfL.

Outcome measures

Outcome measures
Measure
Simufilam 50 mg
n=21 Participants
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=14 Participants
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=19 Participants
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Changes From Baseline in CSF Biomarkers
CSF P-Tau 217
141.9 pg/mL
Standard Deviation 169.08
90.5 pg/mL
Standard Deviation 210.38
10.8 pg/mL
Standard Deviation 139.20
Changes From Baseline in CSF Biomarkers
CSF Total Tau
136.7 pg/mL
Standard Deviation 161.10
92.5 pg/mL
Standard Deviation 152.32
28.7 pg/mL
Standard Deviation 140.48
Changes From Baseline in CSF Biomarkers
CSF GFAP
1939.2 pg/mL
Standard Deviation 2409.36
585.0 pg/mL
Standard Deviation 2062.91
674.8 pg/mL
Standard Deviation 1873.18
Changes From Baseline in CSF Biomarkers
CSF NfL
2372.6 pg/mL
Standard Deviation 2494.67
1334.9 pg/mL
Standard Deviation 2310.62
1535.9 pg/mL
Standard Deviation 3383.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Study Day 1) to Week 76

Population: 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 50 mg

Serious events: 61 serious events
Other events: 198 other events
Deaths: 6 deaths

Simufilam 100 mg

Serious events: 43 serious events
Other events: 184 other events
Deaths: 2 deaths

Placebo

Serious events: 45 serious events
Other events: 195 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
Simufilam 50 mg
n=376 participants at risk
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=374 participants at risk
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=373 participants at risk
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Injury, poisoning and procedural complications
Fall
1.3%
5/376 • Number of events 5 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.80%
3/373 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Hip fracture
0.80%
3/376 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Subdural haematoma
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Acetabulum fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Femoral neck fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Head injury
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Pelvic fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.53%
2/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Accidental poisoning
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Anaemia postoperative
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Fractured sacrum
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Humerus fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Radius fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Spinal fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Sternal fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Vascular graft occlusion
0.27%
1/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Wrist fracture
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Syncope
1.1%
4/376 • Number of events 4 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Transient ischaemic attack
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.80%
3/373 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Cerebrovascular accident
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Dementia Alzheimer's type
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Metabolic encephalopathy
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Presyncope
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Altered state of consciousness
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Brain stem stroke
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Cerebral infarction
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Cerebrospinal fluid leakage
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Dementia
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Dizziness
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Encephalopathy
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Generalised tonic-clonic seizure
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Hypoglycaemic encephalopathy
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Loss of consciousness
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Motor dysfunction
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Normal pressure hydrocephalus
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Seizure
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Subarachnoid haemorrhage
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
COVID-19
0.80%
3/376 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.53%
2/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Pneumonia
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.80%
3/374 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Urinary tract infection
1.1%
4/376 • Number of events 4 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Sepsis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.53%
2/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Diverticulitis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Appendicitis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Escherichia pyelonephritis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Gastroenteritis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Influenza
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Pulmonary sepsis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Pyelonephritis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Urosepsis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Atrial fibrillation
0.53%
2/376 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Atrioventricular block complete
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Cardiac arrest
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Acute myocardial infarction
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Angina pectoris
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Angina unstable
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Cardiac failure congestive
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Coronary artery disease
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Sinus bradycardia
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Sinus node dysfunction
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Supraventricular tachycardia
0.27%
1/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Cardiac disorders
Tachycardia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Colitis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Intestinal obstruction
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Small intestinal obstruction
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Abdominal pain
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Colitis ulcerative
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Dysphagia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Functional gastrointestinal disorder
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Gastritis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Incarcerated inguinal hernia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Inguinal hernia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Large intestine perforation
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Pancreatitis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Acute kidney injury
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Haematuria
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Nephrolithiasis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Renal cyst
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Urethral perforation
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Urethral stenosis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Urinary incontinence
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Renal and urinary disorders
Urinary retention
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
Asthenia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.53%
2/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
Chest pain
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
Death
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
General physical health deterioration
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
Mass
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
Sudden death
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.54%
2/373 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Flank pain
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Fracture pain
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Neck pain
0.27%
1/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Tenosynovitis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Metabolism and nutrition disorders
Hyponatraemia
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.53%
2/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Metabolism and nutrition disorders
Dehydration
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Metabolism and nutrition disorders
Fluid overload
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Investigations
Blood glucose decreased
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Investigations
Blood magnesium decreased
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Investigations
Heart rate increased
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Investigations
Heart rate irregular
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Investigations
Troponin increased
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Aggression
0.53%
2/376 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Anxiety
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Delirium
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Psychotic disorder
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Vascular disorders
Deep vein thrombosis
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Vascular disorders
Aortic occlusion
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Vascular disorders
Shock haemorrhagic
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Vascular disorders
Thrombosis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Blood and lymphatic system disorders
Disseminated intravascular coagulation
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Blood and lymphatic system disorders
Splenic haemorrhage
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/374 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Ear and labyrinth disorders
Vertigo
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Eye disorders
Diplopia
0.00%
0/376 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Hepatobiliary disorders
Cholecystitis
0.27%
1/376 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/373 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.

Other adverse events

Other adverse events
Measure
Simufilam 50 mg
n=376 participants at risk
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Simufilam 100 mg
n=374 participants at risk
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 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 76 weeks at a dose of 50 mg or 100 mg.
Placebo
n=373 participants at risk
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks Placebo: Matching placebo given b.i.d. for 76 weeks
Infections and infestations
COVID-19
12.5%
47/376 • Number of events 48 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
11.5%
43/374 • Number of events 43 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
10.2%
38/373 • Number of events 38 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Urinary tract infection
10.4%
39/376 • Number of events 47 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
8.6%
32/374 • Number of events 40 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
9.1%
34/373 • Number of events 43 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Nasopharyngitis
1.9%
7/376 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.7%
10/374 • Number of events 11 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.4%
9/373 • Number of events 12 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Infections and infestations
Upper respiratory tract infection
2.4%
9/376 • Number of events 9 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.6%
6/374 • Number of events 6 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.6%
6/373 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Dizziness
2.9%
11/376 • Number of events 11 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
7.0%
26/374 • Number of events 29 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
5.9%
22/373 • Number of events 25 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Headache
4.3%
16/376 • Number of events 22 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
4.5%
17/374 • Number of events 18 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.5%
13/373 • Number of events 15 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Nervous system disorders
Syncope
1.1%
4/376 • Number of events 4 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.00%
0/374 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.6%
6/373 • Number of events 7 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Diarrhoea
5.1%
19/376 • Number of events 19 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.7%
14/374 • Number of events 18 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
4.0%
15/373 • Number of events 17 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Nausea
2.4%
9/376 • Number of events 9 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.5%
13/374 • Number of events 19 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
4.0%
15/373 • Number of events 15 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Constipation
1.6%
6/376 • Number of events 7 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.9%
11/374 • Number of events 11 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.9%
11/373 • Number of events 11 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Gastrooesophageal reflux disease
2.1%
8/376 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.1%
4/374 • Number of events 4 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.9%
7/373 • Number of events 7 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Gastrointestinal disorders
Vomiting
1.3%
5/376 • Number of events 5 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.1%
8/374 • Number of events 12 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.6%
6/373 • Number of events 6 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Fall
10.6%
40/376 • Number of events 56 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
8.6%
32/374 • Number of events 50 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
12.9%
48/373 • Number of events 64 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Injury, poisoning and procedural complications
Contusion
2.1%
8/376 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.6%
6/374 • Number of events 7 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.3%
5/373 • Number of events 5 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Anxiety
3.7%
14/376 • Number of events 14 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.5%
13/374 • Number of events 13 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.2%
12/373 • Number of events 13 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Depression
3.2%
12/376 • Number of events 12 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.4%
9/374 • Number of events 9 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
4.3%
16/373 • Number of events 16 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Agitation
4.3%
16/376 • Number of events 16 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.3%
5/374 • Number of events 7 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.8%
14/373 • Number of events 15 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Insomnia
2.1%
8/376 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.1%
8/374 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.6%
6/373 • Number of events 6 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Psychiatric disorders
Confusional state
1.6%
6/376 • Number of events 6 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.1%
8/374 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.27%
1/373 • Number of events 1 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Arthralgia
3.7%
14/376 • Number of events 16 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.2%
12/374 • Number of events 12 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.5%
13/373 • Number of events 14 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Back pain
4.3%
16/376 • Number of events 16 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.5%
13/374 • Number of events 13 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.4%
9/373 • Number of events 11 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Musculoskeletal and connective tissue disorders
Pain in extremity
2.4%
9/376 • Number of events 9 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.53%
2/374 • Number of events 2 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
0.80%
3/373 • Number of events 3 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Investigations
Weight decreased
1.6%
6/376 • Number of events 6 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
4.5%
17/374 • Number of events 18 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.1%
8/373 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
General disorders
Fatigue
4.0%
15/376 • Number of events 15 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
4.3%
16/374 • Number of events 16 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.7%
10/373 • Number of events 10 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Metabolism and nutrition disorders
Decreased appetite
2.4%
9/376 • Number of events 9 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.1%
8/374 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.1%
4/373 • Number of events 4 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Respiratory, thoracic and mediastinal disorders
Cough
2.1%
8/376 • Number of events 8 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
2.1%
8/374 • Number of events 10 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.9%
7/373 • Number of events 10 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
Vascular disorders
Hypertension
2.9%
11/376 • Number of events 11 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
1.3%
5/374 • Number of events 5 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.
3.8%
14/373 • Number of events 14 • Up to 78 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. Study partners were not part of the safety population. No AE data were collected from study partners.

Additional Information

Study Director

Cassava Sciences, Inc.

Phone: 737-910-1045

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