Trial Outcomes & Findings for Non-Interventional Study With Aricept® Evess (NCT NCT00889603)
NCT ID: NCT00889603
Last Updated: 2011-03-31
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, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.
Recruitment status
COMPLETED
Target enrollment
370 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2011-03-31
Participant Flow
Participant milestones
| Measure |
Donepezil
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Overall Study
STARTED
|
370
|
|
Overall Study
COMPLETED
|
333
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Donepezil
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
No longer willing to participant in stud
|
4
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
Non-Interventional Study With Aricept® Evess
Baseline characteristics by cohort
| Measure |
Donepezil
n=370 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Age, Customized
Less than 65 years
|
71 Participants
n=5 Participants
|
|
Age, Customized
65 to 74 years
|
130 Participants
n=5 Participants
|
|
Age, Customized
75 to 84 years
|
142 Participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to 85 years
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.
Outcome measures
| Measure |
Donepezil
n=351 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)
|
1.92 Scores on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 16, and 24Population: FAS. N=number of participants with evaluable data.
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.
Outcome measures
| Measure |
Donepezil
n=348 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Change From Baseline in MMSE Total
Week 8 (N=348)
|
0.92 Scores on a scale
Standard Error 0.09
|
|
Change From Baseline in MMSE Total
Week 16 (N=340)
|
1.56 Scores on a scale
Standard Error 0.12
|
|
Change From Baseline in MMSE Total
Week 24 (N=327)
|
1.97 Scores on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS. Data not analyzed
Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: FAS. N=number of participants with evaluable data.
CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Donepezil
n=351 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
Very much improved
|
5 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
Much improved
|
68 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
Minimally improved
|
194 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
No change
|
74 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
Minimally worse
|
8 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
Much worse
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS. N=number of participants with evaluable data.
CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Donepezil
n=341 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
Very much improved
|
21 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
Much improved
|
119 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
Minimally improved
|
116 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
No change
|
66 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
Minimally worse
|
17 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
Much worse
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: FAS. N=number of participants with evaluable data.
CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Donepezil
n=330 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Minimally improved
|
87 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
No change
|
62 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Minimally worse
|
16 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Much worse
|
2 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Very much improved
|
33 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Much improved
|
129 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Very much worse
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: FAS; LOCF. N=number of participants with evaluable data.
CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Donepezil
n=352 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Very much improved
|
34 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Much improved
|
133 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Minimally improved
|
95 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
No change
|
70 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Minimally worse
|
17 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Much worse
|
2 Participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Very much worse
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24.
Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no').
Outcome measures
| Measure |
Donepezil
n=335 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants in Each Patient Domain of Benefit
Cognition
|
202 Participants
|
|
Number of Participants in Each Patient Domain of Benefit
Functionality
|
215 Participants
|
|
Number of Participants in Each Patient Domain of Benefit
Behavior
|
193 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Population: Safety population; N=number of particpants with evaluable data.
Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor
Outcome measures
| Measure |
Donepezil
n=331 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants With Treatment Tolerability
Very Good
|
186 Participants
|
|
Number of Participants With Treatment Tolerability
Good
|
130 Participants
|
|
Number of Participants With Treatment Tolerability
Moderate
|
14 Participants
|
|
Number of Participants With Treatment Tolerability
Poor
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24Population: Safety population
Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.
Outcome measures
| Measure |
Donepezil
n=370 Participants
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Number of Participants Receiving Other Medications
Baseline
|
205 Participants
|
|
Number of Participants Receiving Other Medications
Week 24
|
270 Participants
|
Adverse Events
Donepezil
Serious events: 12 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donepezil
n=370 participants at risk
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Cardiac failure
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Ventricular fibrillation
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Pneumonia
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Decreased appetite
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Cerebrovascular accident
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Grand mal convulsion
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Transient ischaemic attack
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Abnormal behaviour
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Withdrawal syndrome
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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.
|
|
Renal and urinary disorders
Haematuria
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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 |
Donepezil
n=370 participants at risk
5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Dry mouth
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
3.0%
11/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Irritability
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Weight decreased
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Aphasia
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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 disorder
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
1.4%
5/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Neuralgia
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Partial seizures
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Sedation
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Delusion
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
1.6%
6/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Hypomania
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Impulse-control disorder
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Insomnia
|
3.5%
13/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
Restlessness
|
0.81%
3/370
The same event may appear as both an adverse event (AE) and a Serious AE (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
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.54%
2/370
The same event may appear as both an adverse event (AE) and a Serious AE (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.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.27%
1/370
The same event may appear as both an adverse event (AE) and a Serious AE (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