Trial Outcomes & Findings for Caverject User Study (NCT NCT01008605)
NCT ID: NCT01008605
Last Updated: 2012-04-06
Results Overview
Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Day 1
Results posted on
2012-04-06
Participant Flow
Participant milestones
| Measure |
All Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caverject User Study
Baseline characteristics by cohort
| Measure |
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
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|---|---|
|
Age Continuous
|
51.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Age, Customized
Between 18 and 44 years
|
11 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years
|
31 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.
Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.
Outcome measures
| Measure |
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
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Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
|
95.83 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. Each participant tested one device/dose combination.
Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Outcome measures
| Measure |
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Very useful
|
44 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Somewhat useful
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Not very useful
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Not useful at all
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. Each participant tested one device/dose combination.
Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.
Outcome measures
| Measure |
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Very clear
|
43 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Somewhat clear
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Not very clear
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Not clear at all
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. Each participant tested one device/dose combination.
Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.
Outcome measures
| Measure |
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
No steps particularly difficult
|
38 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Attaching needle
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Mixing solution
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Getting the air out of syringe
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Dialing dose
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Pushing plunger
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Other
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. Each participant tested one device/dose combination.
Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult
Outcome measures
| Measure |
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
Very easy
|
43 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
Somewhat easy
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
Somewhat difficult
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
Very difficult
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. Each participant tested one device/dose combination. n = number of participants with available data.
Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.
Outcome measures
| Measure |
All Participants
n=6 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
n=7 Participants
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
n=5 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Step 1: Assembly (n=6, 6, 6, 7, 6, 5, 6, 6)
|
103.2 seconds
Standard Deviation 16.98
|
141.7 seconds
Standard Deviation 26.17
|
119.2 seconds
Standard Deviation 58.60
|
115.4 seconds
Standard Deviation 33.53
|
127.5 seconds
Standard Deviation 54.57
|
110.2 seconds
Standard Deviation 31.40
|
109.7 seconds
Standard Deviation 28.77
|
107.2 seconds
Standard Deviation 52.70
|
|
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Step 2: Mixing solution (n=6, 5, 6, 7, 5, 5, 6, 6)
|
55.5 seconds
Standard Deviation 28.28
|
57.4 seconds
Standard Deviation 30.94
|
61.0 seconds
Standard Deviation 38.78
|
58.0 seconds
Standard Deviation 37.1
|
50.2 seconds
Standard Deviation 22.97
|
43.8 seconds
Standard Deviation 38.21
|
61.2 seconds
Standard Deviation 16.44
|
51.8 seconds
Standard Deviation 35.31
|
|
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Step 3: De-aerating (n=6, 5, 6, 7, 5, 5, 6, 6)
|
55.8 seconds
Standard Deviation 18.27
|
50.8 seconds
Standard Deviation 18.2
|
62.3 seconds
Standard Deviation 41.55
|
52.7 seconds
Standard Deviation 26.02
|
48.8 seconds
Standard Deviation 43.00
|
44.0 seconds
Standard Deviation 18.12
|
48.2 seconds
Standard Deviation 18.18
|
57.2 seconds
Standard Deviation 20.18
|
|
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Step 4: Setting the dose (n=6, 4, 6, 7, 5, 5, 6, 6
|
21.0 seconds
Standard Deviation 9.65
|
24.8 seconds
Standard Deviation 7.09
|
70.3 seconds
Standard Deviation 106.57
|
47.3 seconds
Standard Deviation 37.80
|
43.2 seconds
Standard Deviation 41.76
|
26.2 seconds
Standard Deviation 14.60
|
23.8 seconds
Standard Deviation 11.37
|
37.3 seconds
Standard Deviation 22.34
|
|
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Step 5: Injecting dose (n=6, 5, 6, 7, 5, 5, 6, 6)
|
98.7 seconds
Standard Deviation 85.41
|
39.2 seconds
Standard Deviation 21.21
|
62.8 seconds
Standard Deviation 68.99
|
80.0 seconds
Standard Deviation 85.65
|
42.0 seconds
Standard Deviation 28.55
|
51.6 seconds
Standard Deviation 42.69
|
31.0 seconds
Standard Deviation 14.34
|
41.5 seconds
Standard Deviation 18.22
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. Each participant tested one device/dose combination.
Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.
Outcome measures
| Measure |
All Participants
n=6 Participants
All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
|
Caverject 10 Mcg Device, 5.0 Mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 7.5 Mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 10 Mcg Device, 10 Mcg Dose Setting
n=7 Participants
Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 5.0 Mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 10.0 Mcg Dose Setting
n=5 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 15.0 Mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
|
Caverject 20 Mcg Device, 20.0 Mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
Instructions provided were useful?
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
Instructions provided were clear?
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
Most difficult step?
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
Syringe easy to use?
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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