Trial Outcomes & Findings for GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease (NCT NCT03823404)
NCT ID: NCT03823404
Last Updated: 2023-02-23
Results Overview
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
643 participants
Primary outcome timeframe
Baseline to Week 48
Results posted on
2023-02-23
Participant Flow
A total of 89 centers worldwide screened subjects and included 57 centers in the United States, 9 centers in the United Kingdom, 8 centers in Spain, 7 centers in Poland, 5 centers in France, and 3 centers in the Netherlands.
Randomized subjects were stratified by baseline Mini-Mental State Examination (MMSE) score (MMSE ≥12 and ≤18, and MMSE ≥19 and ≤24) and Apolipoprotein E genotype (ApoE4 positive either homozygous or heterozygous vs. all others) to assure balanced distribution of mild and moderate Alzheimer's disease and a balanced distribution of ApoE4 subjects, across treatment arms.
Participant milestones
| Measure |
COR388 80 mg BID (Twice Daily)
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
COR388 capsule: BID
|
Placebo BID (Twice Daily)
Placebo capsule: BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
214
|
212
|
217
|
|
Overall Study
COMPLETED
|
129
|
127
|
163
|
|
Overall Study
NOT COMPLETED
|
85
|
85
|
54
|
Reasons for withdrawal
| Measure |
COR388 80 mg BID (Twice Daily)
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
COR388 capsule: BID
|
Placebo BID (Twice Daily)
Placebo capsule: BID
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
35
|
38
|
8
|
|
Overall Study
Withdrawal by Subject
|
38
|
40
|
35
|
|
Overall Study
Death
|
4
|
0
|
0
|
|
Overall Study
Other: Various reasons provided
|
5
|
5
|
6
|
Baseline Characteristics
GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 6.9 • n=93 Participants
|
68.6 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
69.5 years
STANDARD_DEVIATION 6.9 • n=27 Participants
|
69.1 years
STANDARD_DEVIATION 6.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=93 Participants
|
123 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
365 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
278 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
78 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
174 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
187 Participants
n=27 Participants
|
549 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
192 Participants
n=27 Participants
|
574 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=93 Participants
|
13 participants
n=4 Participants
|
8 participants
n=27 Participants
|
31 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=93 Participants
|
143 participants
n=4 Participants
|
152 participants
n=27 Participants
|
447 participants
n=483 Participants
|
|
Region of Enrollment
Poland
|
11 participants
n=93 Participants
|
22 participants
n=4 Participants
|
21 participants
n=27 Participants
|
54 participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=93 Participants
|
12 participants
n=4 Participants
|
13 participants
n=27 Participants
|
49 participants
n=483 Participants
|
|
Region of Enrollment
France
|
10 participants
n=93 Participants
|
8 participants
n=4 Participants
|
10 participants
n=27 Participants
|
28 participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=93 Participants
|
14 participants
n=4 Participants
|
13 participants
n=27 Participants
|
34 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=211 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Baseline
|
23.7 score on a scale
Standard Deviation 8.8
|
23.4 score on a scale
Standard Deviation 8.6
|
23.6 score on a scale
Standard Deviation 9.3
|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Average of Weeks 40/48
|
26.6 score on a scale
Standard Deviation 12.0
|
27.9 score on a scale
Standard Deviation 11.8
|
28.4 score on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=211 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Baseline
|
59.9 score on a scale
Standard Deviation 11.2
|
60.1 score on a scale
Standard Deviation 11.3
|
60.4 score on a scale
Standard Deviation 11.3
|
|
Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Average of Weeks 40/48
|
55.4 score on a scale
Standard Deviation 13.9
|
54.4 score on a scale
Standard Deviation 13.7
|
55.5 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=211 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Baseline
|
5.7 score on a scale
Standard Deviation 2.6
|
6.0 score on a scale
Standard Deviation 2.7
|
5.9 score on a scale
Standard Deviation 2.8
|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Average of Weeks 40/48
|
7.2 score on a scale
Standard Deviation 3.6
|
7.2 score on a scale
Standard Deviation 3.4
|
7.4 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Mini-Mental State Examination (MMSE)
Baseline
|
18.3 score on a scale
Standard Deviation 3.3
|
18.4 score on a scale
Standard Deviation 3.2
|
18.2 score on a scale
Standard Deviation 3.3
|
|
Mini-Mental State Examination (MMSE)
Average of Week 40/48
|
16.9 score on a scale
Standard Deviation 5.7
|
16.4 score on a scale
Standard Deviation 5.7
|
16.2 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders. Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=213 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=216 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Neuropsychiatric Inventory (NPI)
Baseline
|
6.7 score on a scale
Standard Deviation 8.7
|
8.2 score on a scale
Standard Deviation 11.2
|
8.1 score on a scale
Standard Deviation 10.6
|
|
Neuropsychiatric Inventory (NPI)
Average of Weeks 40/48
|
10.7 score on a scale
Standard Deviation 13.7
|
9.2 score on a scale
Standard Deviation 12.1
|
10.4 score on a scale
Standard Deviation 13.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Anti-P. gingivalis immunoglobulin G (IgG) in serum Antibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU) Lower levels represent a pharmacodynamic effect of the drug on its target
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Anti-P. Gingivalis IgG in Serum
Baseline
|
191.6 EU
Standard Deviation 216.8
|
202.4 EU
Standard Deviation 214.0
|
193.1 EU
Standard Deviation 199.5
|
|
Anti-P. Gingivalis IgG in Serum
Week 48
|
77.8 EU
Standard Deviation 123.2
|
110.8 EU
Standard Deviation 184.3
|
134.4 EU
Standard Deviation 201.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Change in magnetic resonance imaging - bilateral whole brain volume Larger volume may represent effect of the drug on its target
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Magnetic Resonance Imaging
Baseline
|
1005154 volume (CM^3)
Standard Deviation 106682
|
1008135 volume (CM^3)
Standard Deviation 105765
|
1001711 volume (CM^3)
Standard Deviation 111145
|
|
Magnetic Resonance Imaging
Week 48
|
982782 volume (CM^3)
Standard Deviation 111888
|
987998 volume (CM^3)
Standard Deviation 102961
|
986119 volume (CM^3)
Standard Deviation 111779
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 48Population: Intent-to-Treat Population
Periodontal (or gum) pocket depth - pocket depth for only sites with depth \>= 4mm. The primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm. Larger measure means worse outcome
Outcome measures
| Measure |
COR388 80 mg BID (Twice Daily)
n=79 Participants
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=64 Participants
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=77 Participants
Placebo capsule: BID
|
|---|---|---|---|
|
Periodontal (or Gum) Pocket Depth
Baseline
|
4.04 mm
Standard Deviation 0.75
|
4.03 mm
Standard Deviation 0.59
|
3.74 mm
Standard Deviation 0.66
|
|
Periodontal (or Gum) Pocket Depth
Week 48
|
3.67 mm
Standard Deviation 0.92
|
3.78 mm
Standard Deviation 0.71
|
3.57 mm
Standard Deviation 0.61
|
Adverse Events
COR388 80 mg BID (Twice Daily)
Serious events: 25 serious events
Other events: 139 other events
Deaths: 5 deaths
COR388 40 mg BID (Twice Daily)
Serious events: 20 serious events
Other events: 150 other events
Deaths: 1 deaths
Placebo BID (Twice Daily)
Serious events: 19 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 participants at risk
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 participants at risk
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 participants at risk
Placebo capsule: BID
|
|---|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Cardiac disorders
bradycardia
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Cardiac disorders
cardiac arrest
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Cardiac disorders
sinus node dysfunction
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
colitis
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
diarrhoea
|
0.93%
2/214 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.94%
2/212 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
gastric perforation
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
gastric ulcer haemorrhage
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
General disorders
general physical health deterioration
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Hepatobiliary disorders
cholecystitis
|
0.93%
2/214 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
abdominal abscess
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
appendicitis
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
clostridium difficile colitis
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.94%
2/212 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.92%
2/217 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
diverticulitis
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
ophthalmic herpes zoster
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
pneumonia
|
0.93%
2/214 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.94%
2/212 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
septic shock
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
urosepsis
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
clavicle fracture
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
femoral neck fracture
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
femur fracture
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
multiple fracture
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
subdural haematoma
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Investigations
liver function test abnormal
|
0.93%
2/214 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Metabolism and nutrition disorders
dehydration
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.94%
2/212 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Metabolism and nutrition disorders
electrolyte imbalance
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
foot deformity
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder cancer
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cholangiocarcinoma
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
gastrointestinal cancer metastatic
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer metastatic
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
oesophageal carcinoma
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer stage II
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
cerebral haemorrhage
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
dementia Alzheimer's type
|
0.93%
2/214 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
headache
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
ischaemic stroke
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
metabolic encephalopathy
|
0.93%
2/214 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
syncope
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
transient ischaemic attack
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
aggression
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
agitation
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
anxiety disorder
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
confusional state
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
hallucination
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
intentional self-injury
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
mental status changes
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.92%
2/217 • Number of events 2 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
psychotic behaviour
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Renal and urinary disorders
renal mass
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.47%
1/212 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Renal and urinary disorders
urinary retention
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Reproductive system and breast disorders
benign prostatic hyperplasia
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Vascular disorders
hypotension
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.47%
1/214 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.00%
0/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.46%
1/217 • Number of events 1 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
Other adverse events
| Measure |
COR388 80 mg BID (Twice Daily)
n=214 participants at risk
COR388 capsule: BID
|
COR388 40 mg BID (Twice Daily)
n=212 participants at risk
COR388 capsule: BID
|
Placebo BID (Twice Daily)
n=217 participants at risk
Placebo capsule: BID
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
5.1%
11/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
3.3%
7/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
1.4%
3/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
diarrhea
|
12.6%
27/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
16.0%
34/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
3.2%
7/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Gastrointestinal disorders
nausea
|
6.1%
13/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
6.1%
13/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
1.8%
4/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Metabolism and nutrition disorders
decreased appetite
|
4.7%
10/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
4.2%
9/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
0.92%
2/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Investigations
ALT increased
|
17.3%
37/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
9.4%
20/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
1.8%
4/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Investigations
AST increased
|
15.9%
34/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
9.4%
20/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
1.4%
3/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Investigations
amylase increased
|
7.5%
16/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
5.7%
12/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
3.7%
8/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
lipase increased
|
9.3%
20/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
6.1%
13/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
5.1%
11/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Nervous system disorders
headache
|
7.0%
15/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
8.5%
18/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
6.5%
14/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Psychiatric disorders
agitation
|
4.7%
10/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
4.2%
9/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
3.2%
7/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Injury, poisoning and procedural complications
fall
|
5.1%
11/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
3.3%
7/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
2.3%
5/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
|
Infections and infestations
urinary tract infection
|
13.1%
28/214 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
7.5%
16/212 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
9.7%
21/217 • Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Individual investigators and/or their associates may publish findings of this study in scientific journals or present them at scientific meetings, provided the Sponsor is given ample opportunity to review any proposed abstract, manuscript, or slide presentation before its submission.
- Publication restrictions are in place
Restriction type: OTHER