Trial Outcomes & Findings for Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets (NCT NCT01089582)
NCT ID: NCT01089582
Last Updated: 2011-04-28
Results Overview
CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.
Recruitment status
COMPLETED
Target enrollment
628 participants
Primary outcome timeframe
Baseline, Week 12.
Results posted on
2011-04-28
Participant Flow
Participant milestones
| Measure |
ARICEPT
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Overall Study
STARTED
|
603
|
|
Overall Study
COMPLETED
|
573
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
ARICEPT
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Other
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets
Baseline characteristics by cohort
| Measure |
ARICEPT
n=603 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Age, Customized
18 to 44 years
|
6 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
44 participants
n=5 Participants
|
|
Age, Customized
65 years or older
|
543 participants
n=5 Participants
|
|
Age, Customized
Unspecified
|
10 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
364 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
238 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unspecified
|
1 participants
n=5 Participants
|
|
Medical History
Anaemia
|
4 participants
n=5 Participants
|
|
Medical History
Iron deficiency anaemia
|
3 participants
n=5 Participants
|
|
Medical History
Aortic valve incompetence
|
1 participants
n=5 Participants
|
|
Medical History
Arrhythmia
|
1 participants
n=5 Participants
|
|
Medical History
Atrial fibrillation
|
7 participants
n=5 Participants
|
|
Medical History
Cardiac failure
|
1 participants
n=5 Participants
|
|
Medical History
Coronary artery disease
|
64 participants
n=5 Participants
|
|
Medical History
Thalassaemia trait
|
1 participants
n=5 Participants
|
|
Medical History
Vertigo
|
4 participants
n=5 Participants
|
|
Medical History
Goitre
|
3 participants
n=5 Participants
|
|
Medical History
Hyperthyroidism
|
7 participants
n=5 Participants
|
|
Medical History
Hypothyroidism
|
16 participants
n=5 Participants
|
|
Medical History
Cataract
|
4 participants
n=5 Participants
|
|
Medical History
Eye disorder
|
1 participants
n=5 Participants
|
|
Medical History
Glaucoma
|
1 participants
n=5 Participants
|
|
Medical History
Colitis
|
1 participants
n=5 Participants
|
|
Medical History
Diverticulum
|
1 participants
n=5 Participants
|
|
Medical History
Diverticulum intestinal
|
1 participants
n=5 Participants
|
|
Medical History
Gastrooesophageal reflux disease
|
3 participants
n=5 Participants
|
|
Medical History
Pancreatitis chronic
|
1 participants
n=5 Participants
|
|
Medical History
Necrosis
|
1 participants
n=5 Participants
|
|
Medical History
Sarcoidosis
|
1 participants
n=5 Participants
|
|
Medical History
Erysipelas
|
1 participants
n=5 Participants
|
|
Medical History
Panencephalitis
|
1 participants
n=5 Participants
|
|
Medical History
Traumatic brain injury
|
1 participants
n=5 Participants
|
|
Medical History
Vitamin B12 decreased
|
1 participants
n=5 Participants
|
|
Medical History
Diabetes mellitus
|
89 participants
n=5 Participants
|
|
Medical History
Dyslipidaemia
|
1 participants
n=5 Participants
|
|
Medical History
Hypercholesterolaemia
|
2 participants
n=5 Participants
|
|
Medical History
Hyperlipidaemia
|
129 participants
n=5 Participants
|
|
Medical History
Hyperuricaemia
|
3 participants
n=5 Participants
|
|
Medical History
Arthritis
|
2 participants
n=5 Participants
|
|
Medical History
Arthropathy
|
1 participants
n=5 Participants
|
|
Medical History
Musculoskeletal pain
|
1 participants
n=5 Participants
|
|
Medical History
Osteoarthritis
|
4 participants
n=5 Participants
|
|
Medical History
Osteoporosis
|
33 participants
n=5 Participants
|
|
Medical History
Rheumatoid arthritis
|
3 participants
n=5 Participants
|
|
Medical History
Haemangioma
|
1 participants
n=5 Participants
|
|
Medical History
Prostate cancer
|
3 participants
n=5 Participants
|
|
Medical History
Carotid artery disease
|
1 participants
n=5 Participants
|
|
Medical History
Cerebral ischaemia
|
51 participants
n=5 Participants
|
|
Medical History
Cerebrovascular accident
|
16 participants
n=5 Participants
|
|
Medical History
Dementia
|
2 participants
n=5 Participants
|
|
Medical History
Diabetic neuropathy
|
1 participants
n=5 Participants
|
|
Medical History
Dystonia
|
1 participants
n=5 Participants
|
|
Medical History
Epilepsy
|
7 participants
n=5 Participants
|
|
Medical History
Extrapyramidal disorder
|
3 participants
n=5 Participants
|
|
Medical History
Headache
|
1 participants
n=5 Participants
|
|
Medical History
Migraine
|
2 participants
n=5 Participants
|
|
Medical History
Motor neurone disease
|
1 participants
n=5 Participants
|
|
Medical History
Multiple sclerosis
|
2 participants
n=5 Participants
|
|
Medical History
Myasthenia gravis
|
1 participants
n=5 Participants
|
|
Medical History
Parkinson's disease
|
16 participants
n=5 Participants
|
|
Medical History
Polyneuropathy
|
2 participants
n=5 Participants
|
|
Medical History
Sciatica
|
2 participants
n=5 Participants
|
|
Medical History
Tremor
|
1 participants
n=5 Participants
|
|
Medical History
Abnormal behaviour
|
2 participants
n=5 Participants
|
|
Medical History
Anxiety disorder
|
3 participants
n=5 Participants
|
|
Medical History
Bipolar disorder
|
1 participants
n=5 Participants
|
|
Medical History
Depression
|
116 participants
n=5 Participants
|
|
Medical History
Neurosis
|
2 participants
n=5 Participants
|
|
Medical History
Personality change due to a general medical condit
|
1 participants
n=5 Participants
|
|
Medical History
Phobia
|
1 participants
n=5 Participants
|
|
Medical History
Psychotic disorder
|
3 participants
n=5 Participants
|
|
Medical History
Psychotic disorder due to a general medical condit
|
2 participants
n=5 Participants
|
|
Medical History
Schizophrenia
|
11 participants
n=5 Participants
|
|
Medical History
Schizophrenia, paranoid type
|
1 participants
n=5 Participants
|
|
Medical History
Sleep disorder
|
3 participants
n=5 Participants
|
|
Medical History
Stress
|
2 participants
n=5 Participants
|
|
Medical History
Glomerulonephritis
|
1 participants
n=5 Participants
|
|
Medical History
Incontinence
|
1 participants
n=5 Participants
|
|
Medical History
Renal failure
|
1 participants
n=5 Participants
|
|
Medical History
Renal failure chronic
|
2 participants
n=5 Participants
|
|
Medical History
Urinary incontinence
|
2 participants
n=5 Participants
|
|
Medical History
Urinary retention
|
1 participants
n=5 Participants
|
|
Medical History
Benign prostatic hyperplasia
|
9 participants
n=5 Participants
|
|
Medical History
Prostatic disorder
|
1 participants
n=5 Participants
|
|
Medical History
Prostatomegaly
|
9 participants
n=5 Participants
|
|
Medical History
Asthma
|
4 participants
n=5 Participants
|
|
Medical History
Chronic obstructive pulmonary disease
|
13 participants
n=5 Participants
|
|
Medical History
Lichen sclerosus
|
1 participants
n=5 Participants
|
|
Medical History
Cardiac operation
|
1 participants
n=5 Participants
|
|
Medical History
Cardiac pacemaker insertion
|
1 participants
n=5 Participants
|
|
Medical History
Oesophageal operation
|
1 participants
n=5 Participants
|
|
Medical History
Arterial disorder
|
1 participants
n=5 Participants
|
|
Medical History
Hypertension
|
273 participants
n=5 Participants
|
|
Medical History
Temporal arteritis
|
1 participants
n=5 Participants
|
|
Medical History
Varicose vein
|
1 participants
n=5 Participants
|
|
Medical History
Venous insufficiency
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12.Population: Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.
CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.
Outcome measures
| Measure |
ARICEPT
n=603 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Missing
|
26 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Not assessed
|
5 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Very much improved
|
27 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Much improved
|
103 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Minimally improved
|
277 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
No change
|
142 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Minimally worse
|
20 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Much worse
|
3 participants
|
|
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Very much worse
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12.Population: FAS.
The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'.
Outcome measures
| Measure |
ARICEPT
n=603 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
Much worse
|
0 participants
|
|
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
Missing
|
39 participants
|
|
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
Much improved
|
54 participants
|
|
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
Improved
|
343 participants
|
|
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
No change
|
140 participants
|
|
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
Worse
|
27 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12.Population: FAS; (n)=number of participants evaluable at baseline and Week 12.
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
Outcome measures
| Measure |
ARICEPT
n=581 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Physical health
|
0.1 scores on a scale
Standard Deviation 0.51
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Energy
|
0.2 scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Mood
|
0.3 scores on a scale
Standard Deviation 0.70
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Living situation
|
0.2 scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Memory
|
0.3 scores on a scale
Standard Deviation 0.61
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Family
|
0.1 scores on a scale
Standard Deviation 0.56
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Marriage
|
0.1 scores on a scale
Standard Deviation 0.55
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Friends
|
0.1 scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Self as a whole
|
0.1 scores on a scale
Standard Deviation 0.57
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Ability to do chores around the house
|
0.2 scores on a scale
Standard Deviation 0.69
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Ability to do things for fun
|
0.3 scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Money
|
0.1 scores on a scale
Standard Deviation 0.57
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Life as a whole
|
0.2 scores on a scale
Standard Deviation 0.59
|
|
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Overall score
|
2.3 scores on a scale
Standard Deviation 4.33
|
PRIMARY outcome
Timeframe: Baseline, Week 12.Population: FAS; (n)=number of participants evaluable at baseline and Week 12.
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
Outcome measures
| Measure |
ARICEPT
n=564 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Physical health
|
0.1 scores on a scale
Standard Deviation 0.54
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Energy
|
0.2 scores on a scale
Standard Deviation 0.65
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Mood
|
0.3 scores on a scale
Standard Deviation 0.72
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Living situation
|
0.2 scores on a scale
Standard Deviation 0.62
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Memory
|
0.3 scores on a scale
Standard Deviation 0.67
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Family
|
0.1 scores on a scale
Standard Deviation 0.52
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Marriage
|
0.1 scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Friends
|
0.1 scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Self as a whole
|
0.1 scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Ability to do chores around the house
|
0.2 scores on a scale
Standard Deviation 0.66
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Ability to do things for fun
|
0.2 scores on a scale
Standard Deviation 0.66
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Money
|
0.1 scores on a scale
Standard Deviation 0.62
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Life as a whole
|
0.1 scores on a scale
Standard Deviation 0.53
|
|
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
Overall score
|
2.0 scores on a scale
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: Baseline to Week 12.Population: FAS. Starting dose of ARICEPT was not summarized.
The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.
Outcome measures
| Measure |
ARICEPT
n=603 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
Missing
|
198 participants
|
|
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
0 weeks up to less than 4 weeks
|
77 participants
|
|
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
4 weeks up to less than 6 weeks
|
267 participants
|
|
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
6 weeks up to less than 8 weeks
|
19 participants
|
|
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
8 weeks up to less than 10 weeks
|
13 participants
|
|
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
10 weeks or later
|
29 participants
|
SECONDARY outcome
Timeframe: Week 12.Population: FAS.
Outcome measures
| Measure |
ARICEPT
n=603 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
Missing
|
8 participants
|
|
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
5 mg
|
193 participants
|
|
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
10 mg
|
400 participants
|
|
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
greater than 10 mg
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12.Population: FAS.
The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.
Outcome measures
| Measure |
ARICEPT
n=603 Participants
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Missing
|
9 participants
|
|
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Very good
|
386 participants
|
|
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Good
|
161 participants
|
|
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Adequate
|
26 participants
|
|
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Unstatisfactory
|
13 participants
|
|
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Unevaluable
|
8 participants
|
Adverse Events
ARICEPT
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARICEPT
n=603 participants at risk
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
General disorders
Death
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
ARICEPT
n=603 participants at risk
ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
|
|---|---|
|
Psychiatric disorders
Dysthymic disorder
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Illusion
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
8/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.33%
2/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.00%
6/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.00%
6/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
International normalised ratio increased
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.66%
4/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
1.00%
6/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Aggression
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.33%
2/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.33%
2/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Behavioural and psychiatric symptoms of dementia
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.33%
2/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.17%
1/603
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER