Trial Outcomes & Findings for Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease (NCT NCT00744978)
NCT ID: NCT00744978
Last Updated: 2011-11-22
Results Overview
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Week 6
Results posted on
2011-11-22
Participant Flow
Each participant was to complete a 3-week placebo run-in period then receive a treatment sequence of either varenicline followed by placebo, or placebo followed by varenicline, separated by a 3-week placebo washout period. Of 92 participants screened, 66 participants were randomized to treatment.
Participant milestones
| Measure |
Varenicline Then Placebo
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
|
Placebo Then Varenicline
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
|
|---|---|---|
|
Period 1
STARTED
|
32
|
34
|
|
Period 1
Treated
|
31
|
33
|
|
Period 1
COMPLETED
|
26
|
29
|
|
Period 1
NOT COMPLETED
|
6
|
5
|
|
Placebo Washout
STARTED
|
26
|
29
|
|
Placebo Washout
COMPLETED
|
26
|
29
|
|
Placebo Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
26
|
29
|
|
Period 2
COMPLETED
|
26
|
28
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Varenicline Then Placebo
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
|
Placebo Then Varenicline
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
|
|---|---|---|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
0
|
2
|
|
Period 1
Other
|
0
|
2
|
|
Period 1
Adverse Event
|
4
|
0
|
|
Period 1
Randomized but not Treated
|
1
|
1
|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Varenicline Then Placebo
n=32 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
|
Placebo Then Varenicline
n=34 Participants
Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day \[QD\]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
71.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
73.9 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
72.7 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Full analysis set (FAS): all participants who were randomized and took at least 1 dose of randomized study medication. N = number of participants with ADAS-Cog 75 results at Week 6.
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.
Outcome measures
| Measure |
Varenicline
n=53 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6
|
18.07 units on scale
Standard Error 0.942
|
18.49 units on scale
Standard Error 0.939
|
SECONDARY outcome
Timeframe: Week 3Population: FAS; N = number of participants with ADAS-Cog 75 results at Week 3.
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3
|
19.87 units on scale
Standard Error 0.935
|
19.31 units on scale
Standard Error 0.941
|
SECONDARY outcome
Timeframe: Week 3Population: FAS. N = number of participants with ADAS-Cog 70 results at Week 3.
11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3
|
19.60 units on scale
Standard Error 0.880
|
19.01 units on scale
Standard Error 0.885
|
SECONDARY outcome
Timeframe: Week 6Population: FAS. N = number of participants with ADAS-Cog 70 results at Week 6.
11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.
Outcome measures
| Measure |
Varenicline
n=53 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6
|
17.86 units on scale
Standard Error 0.886
|
18.23 units on scale
Standard Error 0.884
|
SECONDARY outcome
Timeframe: Week 6Population: FAS; N = number of participants with a CGI-I score at Week 6.
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is 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 |
Varenicline
n=54 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6
|
3.71 units on a scale
Standard Error 0.103
|
3.70 units on a scale
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Week 3Population: FAS. N = number of participants with a NPI total score at Week 3.
Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms \* severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.
Outcome measures
| Measure |
Varenicline
n=59 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Neuropsychiatric Inventory (NPI) Total Score at Week 3
|
2.97 scores on scale
Standard Error 0.845
|
2.29 scores on scale
Standard Error 0.858
|
SECONDARY outcome
Timeframe: Week 6Population: FAS. N = number of participants with a NPI total score at Week 6.
Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms \* severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.
Outcome measures
| Measure |
Varenicline
n=54 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Neuropsychiatric Inventory (NPI) Total Score at Week 6
|
3.82 scores on scale
Standard Error 0.857
|
2.55 scores on scale
Standard Error 0.855
|
SECONDARY outcome
Timeframe: Week 1Population: FAS; N = number of participants with a CogState score for Detection at Week 1.
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 \[5000\]) were excluded as reflecting responses that were abnormally slow.
Outcome measures
| Measure |
Varenicline
n=59 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=56 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1
|
2.65 log10 millisecond
Standard Error 0.015
|
2.64 log10 millisecond
Standard Error 0.015
|
SECONDARY outcome
Timeframe: Week 3Population: FAS; N = number of participants with a CogState score for Detection at Week 3.
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 \[5000\]) were excluded as reflecting responses that were abnormally slow.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3
|
2.65 log10 millisecond
Standard Error 0.015
|
2.63 log10 millisecond
Standard Error 0.015
|
SECONDARY outcome
Timeframe: Week 6Population: FAS; N = number of participants with a CogState score for Detection at Week 6.
Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 \[5000\]) were excluded as reflecting responses that were abnormally slow.
Outcome measures
| Measure |
Varenicline
n=53 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6
|
2.64 log10 millisecond
Standard Error 0.015
|
2.65 log10 millisecond
Standard Error 0.015
|
SECONDARY outcome
Timeframe: Week 1Population: FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 1.
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.
Outcome measures
| Measure |
Varenicline
n=59 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=56 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1
|
38.52 errors
Standard Error 2.586
|
40.05 errors
Standard Error 2.626
|
SECONDARY outcome
Timeframe: Week 3Population: FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 3.
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3
|
39.43 errors
Standard Error 2.600
|
43.57 errors
Standard Error 2.656
|
SECONDARY outcome
Timeframe: Week 6Population: FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 6.
Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.
Outcome measures
| Measure |
Varenicline
n=53 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6
|
41.67 errors
Standard Error 2.668
|
42.98 errors
Standard Error 2.641
|
SECONDARY outcome
Timeframe: Week 1Population: FAS; N = number of participants with a CogState score for One Back Working Memory at Week 1.
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
Outcome measures
| Measure |
Varenicline
n=59 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=56 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1
|
0.94 arcsine proportion correct
Standard Error 0.031
|
0.94 arcsine proportion correct
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Week 3Population: FAS; N = number of participants with a CogState score for One Back Working Memory at Week 3.
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3
|
0.96 arcsine proportion correct
Standard Error 0.031
|
0.97 arcsine proportion correct
Standard Error 0.032
|
SECONDARY outcome
Timeframe: Week 6Population: FAS; N = number of participants with a CogState score for One Back Working Memory at Week 6.
Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
Outcome measures
| Measure |
Varenicline
n=53 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6
|
0.95 arcsine proportion correct
Standard Error 0.032
|
0.96 arcsine proportion correct
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Week 1Population: FAS; N = number of participants with a CogState score for Visual Learning at Week 1.
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease \[AD\], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
Outcome measures
| Measure |
Varenicline
n=59 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=56 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1
|
0.83 arcsine proportion correct
Standard Error 0.015
|
0.81 arcsine proportion correct
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Week 3Population: FAS; N = number of participants with a CogState score for Visual Learning at Week 3.
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease \[AD\], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3
|
0.82 arcsine proportion correct
Standard Error 0.016
|
0.82 arcsine proportion correct
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Week 6Population: FAS; N = number of participants with a CogState score for Visual Learning at Week 6.
Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease \[AD\], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.
Outcome measures
| Measure |
Varenicline
n=53 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6
|
0.83 arcsine proportion correct
Standard Error 0.016
|
0.84 arcsine proportion correct
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Week 1Population: FAS; N = number of participants with a CogState score for Identification at Week 1.
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 \[5000\]) were excluded as reflecting responses that were abnormally slow.
Outcome measures
| Measure |
Varenicline
n=59 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=56 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1
|
2.79 log10 millisecond
Standard Error 0.011
|
2.80 log10 millisecond
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Week 3Population: FAS; N = number of participants with a CogState score for Identification at Week 3.
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 \[5000\]) were excluded as reflecting responses that were abnormally slow.
Outcome measures
| Measure |
Varenicline
n=58 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=54 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3
|
2.79 log10 millisecond
Standard Error 0.011
|
2.80 log10 millisecond
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Week 6Population: FAS; N = number of participants with a CogState score for Identification at Week 6.
Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 \[5000\]) were excluded as reflecting responses that were abnormally slow.
Outcome measures
| Measure |
Varenicline
n=52 Participants
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=55 Participants
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6
|
2.79 log10 millisecond
Standard Error 0.012
|
2.79 log10 millisecond
Standard Error 0.011
|
Adverse Events
Varenicline
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=60 participants at risk
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=59 participants at risk
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
General disorders
Asthenia
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.7%
1/60
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.
|
0.00%
0/59
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 |
Varenicline
n=60 participants at risk
Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
|
Placebo
n=59 participants at risk
Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
|
|---|---|---|
|
Ear and labyrinth disorders
External ear inflammation
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Eye disorders
Cataract
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Eye disorders
Eye disorder
|
1.7%
1/60
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.
|
0.00%
0/59
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
Abdominal discomfort
|
3.3%
2/60
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.
|
0.00%
0/59
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
Abdominal pain
|
1.7%
1/60
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.
|
0.00%
0/59
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
Abdominal pain lower
|
0.00%
0/60
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.
|
1.7%
1/59
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
Abdominal pain upper
|
3.3%
2/60
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.
|
3.4%
2/59
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
Constipation
|
5.0%
3/60
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.
|
3.4%
2/59
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
|
3.3%
2/60
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.
|
1.7%
1/59
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
Dry mouth
|
3.3%
2/60
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.
|
0.00%
0/59
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
Duodenal ulcer
|
0.00%
0/60
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.
|
1.7%
1/59
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
Dyspepsia
|
6.7%
4/60
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.
|
1.7%
1/59
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
Gastric disorder
|
1.7%
1/60
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.
|
0.00%
0/59
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
Gastritis haemorrhagic
|
0.00%
0/60
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.
|
1.7%
1/59
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
Inguinal hernia
|
1.7%
1/60
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.
|
1.7%
1/59
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
|
28.3%
17/60
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.
|
3.4%
2/59
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
Stomatitis
|
1.7%
1/60
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.
|
1.7%
1/59
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
|
20.0%
12/60
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.
|
0.00%
0/59
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
Asthenia
|
3.3%
2/60
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.
|
1.7%
1/59
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
|
3.3%
2/60
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.
|
1.7%
1/59
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
Feeling abnormal
|
1.7%
1/60
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.
|
1.7%
1/59
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
Hunger
|
1.7%
1/60
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.
|
1.7%
1/59
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
Malaise
|
1.7%
1/60
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.
|
0.00%
0/59
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
Oedema peripheral
|
0.00%
0/60
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.
|
1.7%
1/59
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
Pyrexia
|
1.7%
1/60
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.
|
0.00%
0/59
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
Bronchitis
|
3.3%
2/60
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.
|
0.00%
0/59
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
|
3.3%
2/60
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.
|
6.8%
4/59
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
Upper respiratory tract infection
|
1.7%
1/60
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.
|
0.00%
0/59
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
Urinary tract infection
|
3.3%
2/60
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.
|
3.4%
2/59
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.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.7%
1/60
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.
|
0.00%
0/59
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
Alanine aminotransferase increased
|
1.7%
1/60
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.
|
1.7%
1/59
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
Aspartate aminotransferase increased
|
1.7%
1/60
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.
|
1.7%
1/59
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
Urine analysis abnormal
|
1.7%
1/60
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.
|
0.00%
0/59
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
Weight decreased
|
1.7%
1/60
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.
|
1.7%
1/59
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
White blood cells urine positive
|
1.7%
1/60
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.
|
1.7%
1/59
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
Decreased appetite
|
21.7%
13/60
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.
|
10.2%
6/59
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
Hypercholesterolaemia
|
1.7%
1/60
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.
|
1.7%
1/59
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
Hypokalaemia
|
3.3%
2/60
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.
|
1.7%
1/59
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
2/60
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.
|
3.4%
2/59
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.7%
1/60
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.
|
0.00%
0/59
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
Dementia Alzheimer's type
|
1.7%
1/60
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.
|
0.00%
0/59
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
|
13.3%
8/60
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.
|
0.00%
0/59
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
|
11.7%
7/60
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.
|
6.8%
4/59
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
Intention tremor
|
1.7%
1/60
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.
|
1.7%
1/59
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
Lethargy
|
1.7%
1/60
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.
|
0.00%
0/59
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
Paraesthesia
|
1.7%
1/60
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.
|
0.00%
0/59
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
Somnolence
|
1.7%
1/60
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.
|
1.7%
1/59
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
|
3.3%
2/60
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.
|
0.00%
0/59
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
Depressed mood
|
0.00%
0/60
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.
|
1.7%
1/59
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
|
0.00%
0/60
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.
|
1.7%
1/59
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
Insomnia
|
3.3%
2/60
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.
|
0.00%
0/59
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
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
2/60
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.
|
0.00%
0/59
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/60
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.
|
3.4%
2/59
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.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/60
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.
|
0.00%
0/59
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/60
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.
|
1.7%
1/59
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.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.7%
1/60
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.
|
1.7%
1/59
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.
|
|
Vascular disorders
Hypertension
|
3.3%
2/60
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.
|
0.00%
0/59
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.
|
|
Vascular disorders
Intermittent claudication
|
1.7%
1/60
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.
|
1.7%
1/59
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