Trial Outcomes & Findings for Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease (NCT NCT02079246)
NCT ID: NCT02079246
Last Updated: 2018-08-10
Results Overview
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1463 participants
Primary outcome timeframe
Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
Results posted on
2018-08-10
Participant Flow
Open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641)
Participant milestones
| Measure |
Idalopirdine 60 mg
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg + Memantine
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
|
|---|---|---|
|
OLEX
STARTED
|
1463
|
0
|
|
OLEX
COMPLETED
|
1235
|
0
|
|
OLEX
NOT COMPLETED
|
228
|
0
|
|
OLEX-MEM
STARTED
|
0
|
101
|
|
OLEX-MEM
COMPLETED
|
0
|
82
|
|
OLEX-MEM
NOT COMPLETED
|
0
|
19
|
Reasons for withdrawal
| Measure |
Idalopirdine 60 mg
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg + Memantine
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
|
|---|---|---|
|
OLEX
Withdrawal before treatment
|
1
|
0
|
|
OLEX
Death
|
11
|
0
|
|
OLEX
Adverse Event
|
66
|
0
|
|
OLEX
Withdrawal by Subject
|
60
|
0
|
|
OLEX
Lost to Follow-up
|
6
|
0
|
|
OLEX
Protocol Violation
|
6
|
0
|
|
OLEX
Lack of Efficacy
|
3
|
0
|
|
OLEX
Results of the lead-in studies
|
58
|
0
|
|
OLEX
Other: Disallowed medication
|
8
|
0
|
|
OLEX
Other: Insufficient compliance
|
2
|
0
|
|
OLEX
Other: Caregiver unavailable
|
3
|
0
|
|
OLEX
Other: Coordinator decision
|
1
|
0
|
|
OLEX
Other: Worsening of condition
|
1
|
0
|
|
OLEX
Other: Moved to nursing home
|
1
|
0
|
|
OLEX
Other: Withdrawal of caregiver consent
|
1
|
0
|
|
OLEX-MEM
Adverse Event
|
0
|
6
|
|
OLEX-MEM
Withdrawal by Subject
|
0
|
7
|
|
OLEX-MEM
Protocol Violation
|
0
|
2
|
|
OLEX-MEM
Lost to Follow-up
|
0
|
1
|
|
OLEX-MEM
Other: Moved to nursing home
|
0
|
3
|
Baseline Characteristics
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Idalopirdine 60 mg
n=1462 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
|---|---|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
922 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
540 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1224 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1318 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
135 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
236 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
12 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
139 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
79 participants
n=5 Participants
|
|
Region of Enrollment
France
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
119 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
47 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
82 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)Population: All patients who took at least one dose of IMP in the OLEX.
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
Outcome measures
| Measure |
Idalopirdine 60 mg
n=1462 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
|
2130 TEAEs
|
—
|
PRIMARY outcome
Timeframe: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)Population: All patients who took at least one dose of IMP or memantine in the OLEX-MEM.
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=101 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Number of TEAEs in the OLEX-MEM
|
93 TEAEs
|
—
|
SECONDARY outcome
Timeframe: Baseline II (start of OLEX, Week 0) to Week 28Population: All patients in who took at least one dose of IMP in the OLEX.
Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The ADAS-cog is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=693 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
n=602 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Change in Cognition
|
3.01 units on a scale
Standard Error 0.22
|
2.67 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Week 28Population: All patients in who took at least one dose of IMP in the OLEX.
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=693 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
n=594 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Clinical Global Impression Score
|
4.58 units on a scale
Standard Error 0.005
|
4.61 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline II (start of OLEX, Week 0) to Week 28Population: All patients in who took at least one dose of IMP in the OLEX.
Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The ADCS-ADL23 is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=696 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
n=601 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Change in Daily Functioning
|
-3.71 units on a scale
Standard Error 0.28
|
-3.88 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline II (start of OLEX, Week 0) to Week 28Population: All patients in who took at least one dose of IMP in the OLEX.
Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score. The NPI is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 \[occasionally\] to 4 \[very frequent\]) and severity (a 3-point scale from 1 \[mild\] to 3 \[marked\]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=697 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
n=602 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Change in Behavioural Disturbance
|
1.80 units on a scale
Standard Error 0.35
|
1.36 units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline II (start of OLEX, Week 0) to Week 28Population: All patients in who took at least one dose of IMP in the OLEX.
Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=730 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
n=646 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Change in Cognitive Aspects of Mental Function
|
-1.28 units on a scale
Standard Error 0.10
|
-1.02 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline III (start of OLEX-MEM, Week 28) to Week 52Population: All patients who took at least one dose of IMP or memantine in the OLEX-MEM.
Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).
Outcome measures
| Measure |
Idalopirdine 60 mg
n=93 Participants
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862A
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Patients from lead-in Study 14682A
|
|---|---|---|
|
Change in Cognitive Aspects of Mental Function
|
-0.55 units on a scale
Standard Error 0.26
|
—
|
Adverse Events
Idalopirdine 60 mg
Serious events: 91 serious events
Other events: 182 other events
Deaths: 11 deaths
Idalopirdine 60 mg + Memantine
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idalopirdine 60 mg
n=1462 participants at risk
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg + Memantine
n=101 participants at risk
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
|
|---|---|---|
|
Reproductive system and breast disorders
Breast mass
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Angina pectoris
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Atrial tachycardia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Atrioventricular block
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Bradycardia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Cardiac arrest
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Cardiac failure congestive
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Myocardial infarction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Eye disorders
Cataract
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Eye disorders
Iris adhesions
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Eye disorders
Retinal detachment
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Eye disorders
Retinopathy proliferative
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Colitis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Constipation
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Enteritis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
General disorders
Exercise tolerance decreased
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
General disorders
Pyrexia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Bacteraemia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Escherichia sepsis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Gastroenteritis viral
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Hepatitis e
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Herpes zoster
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Influenza
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Lung infection
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Otitis media
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Peritonitis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Pneumonia
|
0.21%
3/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Pneumonia bacterial
|
0.27%
4/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Septic shock
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Contusion
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
6/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Head injury
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Blood creatinine increased
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Blood potassium decreased
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Metabolism and nutrition disorders
Dehydration
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of cervix uteri
|
0.11%
1/922 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/69 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Balance disorder
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Brain stem infarction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dementia
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Intracranial haematoma
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Ischaemic stroke
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Loss of consciousness
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.99%
1/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Partial seizures
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Presyncope
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Seizure
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Syncope
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Transient ischaemic attack
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Product Issues
Device malfunction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Abnormal behaviour
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Aggression
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Agitation
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Confusional state
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Delirium
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Delusion
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Depressive symptom
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Grief reaction
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Psychotic disorder
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Sleep disorder
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Renal and urinary disorders
Calculus urinary
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Renal and urinary disorders
Urinary retention
|
0.14%
2/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
1/540 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/32 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.99%
1/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Surgical and medical procedures
Cataract operation
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Orthostatic hypotension
|
0.07%
1/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
Other adverse events
| Measure |
Idalopirdine 60 mg
n=1462 participants at risk
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
|
Idalopirdine 60 mg + Memantine
n=101 participants at risk
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
7.2%
105/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
6/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Fall
|
5.5%
80/1462 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
0.99%
1/101 • From Baseline II (week 0) to week 28 (week 32, including safety follow-up, for patients who did not continue in OLEX-MEM) for OLEX. From Baseline III (week 28) to week 56 (including safety follow-up) for OLEX-MEM.
Treatment-Emergent Adverse Events are reported in this section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place