Trial Outcomes & Findings for A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431) (NCT NCT00543855)
NCT ID: NCT00543855
Last Updated: 2013-03-08
Results Overview
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Baseline and every 4 weeks up to 12 weeks
Results posted on
2013-03-08
Participant Flow
167 participants initiated the Observation period, 140 participants were enrolled in the treatment period, one participant did not receive treatment.
Participant milestones
| Measure |
3 mg Donepezil Hydrochloride
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).
|
Placebo
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
37
|
34
|
|
Overall Study
COMPLETED
|
31
|
31
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
6
|
4
|
Reasons for withdrawal
| Measure |
3 mg Donepezil Hydrochloride
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).
|
Placebo
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Baseline characteristics by cohort
| Measure |
3 mg Donepezil Hydrochloride
n=35 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=37 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=34 Participants
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
79.6 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
77.9 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
78.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
78.7 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
78.7 years
STANDARD_DEVIATION 5.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks up to 12 weeksPopulation: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Outcome measures
| Measure |
3 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=31 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=30 Participants
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
Change from Baseline (LOCF)
|
1.2 Score on a scale
Standard Deviation 3.8
|
3.5 Score on a scale
Standard Deviation 3.2
|
2.3 Score on a scale
Standard Deviation 3.2
|
-0.6 Score on a scale
Standard Deviation 2.7
|
|
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
Baseline
|
20.1 Score on a scale
Standard Deviation 4.2
|
19.7 Score on a scale
Standard Deviation 4.4
|
19.7 Score on a scale
Standard Deviation 4.5
|
18.2 Score on a scale
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks up to 12 weeksPopulation: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated "worse neuropsychiatric outcomes." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Outcome measures
| Measure |
3 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=31 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=30 Participants
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
Baseline
|
20.9 Score on a scale
Standard Deviation 13.1
|
14.2 Score on a scale
Standard Deviation 8.4
|
19.1 Score on a scale
Standard Deviation 11.8
|
18.4 Score on a scale
Standard Deviation 8.9
|
|
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
Change from Baseline (LOCF)
|
-4.3 Score on a scale
Standard Deviation 21.5
|
-5.9 Score on a scale
Standard Deviation 6.5
|
-10.2 Score on a scale
Standard Deviation 12.0
|
-3.1 Score on a scale
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Outcome measures
| Measure |
3 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=31 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=30 Participants
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Marked improvement
|
3.6 Percentage of Participants
|
17.9 Percentage of Participants
|
3.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Moderate Improvement
|
17.9 Percentage of Participants
|
17.9 Percentage of Participants
|
11.5 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Minimal Improvement
|
50.0 Percentage of Participants
|
35.7 Percentage of Participants
|
50.0 Percentage of Participants
|
29.6 Percentage of Participants
|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
No Change
|
21.4 Percentage of Participants
|
14.3 Percentage of Participants
|
30.8 Percentage of Participants
|
18.5 Percentage of Participants
|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Minimal Worsening
|
3.6 Percentage of Participants
|
7.1 Percentage of Participants
|
3.8 Percentage of Participants
|
37.0 Percentage of Participants
|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Moderate Worsening
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Marked Worsening
|
3.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia. ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Outcome measures
| Measure |
3 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=31 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=33 Participants
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=30 Participants
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
Baseline
|
28.3 Score on a scale
Standard Deviation 14.4
|
23.2 Score on a scale
Standard Deviation 11.6
|
26.9 Score on a scale
Standard Deviation 16.3
|
22.3 Score on a scale
Standard Deviation 9.8
|
|
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
Change from Baseline (LOCF)
|
-1.3 Score on a scale
Standard Deviation 11.1
|
-0.6 Score on a scale
Standard Deviation 16.4
|
-5.2 Score on a scale
Standard Deviation 13.8
|
2.9 Score on a scale
Standard Deviation 9.1
|
Adverse Events
3 mg Donepezil Hydrochloride
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
5 mg Donepezil Hydrochloride
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
10 mg Donepezil Hydrochloride
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 mg Donepezil Hydrochloride
n=35 participants at risk
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=33 participants at risk
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=37 participants at risk
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=34 participants at risk
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Psychiatric disorders
Hallucination
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Nervous system disorders
Cerebral Infarction
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
Other adverse events
| Measure |
3 mg Donepezil Hydrochloride
n=35 participants at risk
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
5 mg Donepezil Hydrochloride
n=33 participants at risk
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
|
10 mg Donepezil Hydrochloride
n=37 participants at risk
E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
|
Placebo
n=34 participants at risk
Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.6%
3/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
10.8%
4/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.1%
3/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.4%
2/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Psychiatric disorders
Poriomania
|
5.7%
2/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Nervous system disorders
Parkinsonism
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
12.1%
4/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.1%
3/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
11.8%
4/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
9.1%
3/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Dental Caries
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.4%
2/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.7%
2/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.4%
2/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.8%
3/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.9%
2/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
General disorders
Malaise
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
14.3%
5/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
9.1%
3/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
13.5%
5/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.9%
2/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Blood Pressure Increased
|
14.3%
5/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.4%
2/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Blood Urine Present
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
10.8%
4/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.8%
3/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Blood Triglycerides Increased
|
5.7%
2/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.8%
3/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Glucose Urine Present
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.1%
3/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
10.8%
4/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Blood Urea Increased
|
2.9%
1/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.9%
2/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
8.8%
3/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.9%
2/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Investigations
Protein Urine Present
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
2/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
6.1%
2/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.7%
1/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
2.9%
1/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/35
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
3.0%
1/33
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
5.4%
2/37
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
0.00%
0/34
Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
|
Additional Information
Masaki Nakagawa, Study Director
Eisai Co., Ltd.
Phone: +81-3-3817-5245
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place