Healthy
Conditions
Keywords
usability study
Brief summary
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
Detailed description
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use
Interventions
OTHERdual-chamber syringe
dual-chamber syringe for mock injection
Sponsors
Pfizer
Study design
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males
Exclusion criteria
* Inability to read English; * physical limitations preventing participant from operating the syringe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery System Success Rate (DSSR) | Day 1 | DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/hands on demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Day 1 | Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all. |
| Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Day 1 | Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other. |
| Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Day 1 | Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult. |
| Number of Participants Providing Responses to Any Question on the PAT | Day 1 | Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use? |
| Time Required to Perform Segments 1 to 5 | Day 1 | Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System). |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Day 1 | OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A No answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Day 1 | OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components. |
| Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Day 1 | OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Day 1 | OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Day 1 | OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution. |
| Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Day 1 | Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Day 1 | OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Day 1 | OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe. |
| Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Day 1 | OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Day 1 | OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Day 1 | OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Day 1 | OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Day 1 | OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A Yes response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Day 1 | OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Day 1 | OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Day 1 | OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection. |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Day 1 | OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe. |
Countries
United States
Participant flow
Pre-assignment details
A total of 50 participants were screened, among whom 2 did not meet entrance criteria. The remaining 48 participants did and were randomized to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 10 mcg Device - 5 mcg Dose Setting Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 10 mcg Device - 10 mcg Dose Setting Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 20 mcg Device - 5 mcg Dose Setting Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 20 mcg Device - 10 mcg Dose Setting Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 20 mcg Device - 15 mcg Dose Setting Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Caverject 20 mcg Device - 20 mcg Dose Setting Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication. | 6 |
| Total | 48 |
Baseline characteristics
| Characteristic | Caverject 10 mcg Device - 2.5 mcg Dose Setting | Caverject 10 mcg Device - 5 mcg Dose Setting | Caverject 10 mcg Device - 7.5 mcg Dose Setting | Caverject 10 mcg Device - 10 mcg Dose Setting | Caverject 20 mcg Device - 5 mcg Dose Setting | Caverject 20 mcg Device - 10 mcg Dose Setting | Caverject 20 mcg Device - 15 mcg Dose Setting | Caverject 20 mcg Device - 20 mcg Dose Setting | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 9.1 | 52.7 years STANDARD_DEVIATION 10 | 51.3 years STANDARD_DEVIATION 9 | 53.5 years STANDARD_DEVIATION 9 | 63.0 years STANDARD_DEVIATION 2.5 | 55.3 years STANDARD_DEVIATION 4.8 | 57.8 years STANDARD_DEVIATION 6.8 | 51.8 years STANDARD_DEVIATION 5.6 | 54.8 years STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Delivery System Success Rate (DSSR)
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/hands on demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
Time frame: Day 1
Population: The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Delivery System Success Rate (DSSR) | 66.67 percentage of participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Delivery System Success Rate (DSSR) | 66.67 percentage of participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Delivery System Success Rate (DSSR) | 100.00 percentage of participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Delivery System Success Rate (DSSR) | 100.00 percentage of participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Delivery System Success Rate (DSSR) | 100.00 percentage of participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Delivery System Success Rate (DSSR) | 83.33 percentage of participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Delivery System Success Rate (DSSR) | 100.00 percentage of participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Delivery System Success Rate (DSSR) | 100.00 percentage of participants |
| All Participants | Delivery System Success Rate (DSSR) | 89.58 percentage of participants |
Secondary
Number of Participants Providing Responses to Any Question on the PAT
Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 6 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 1 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 6 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 1 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 5 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Syringe easy to use? | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Most difficult step? | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | What step did you stop? Why? | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were clear? | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Providing Responses to Any Question on the PAT | Instructions provided were useful? | 6 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A No answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components.
Time frame: Day 1
Population: FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 6 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | No (FAIL per OAT) | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Yes | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | No | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A Yes response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 4 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 4 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 1 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Yes (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | No | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | No | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Yes | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | No | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as not applicable as they tested the full dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 6 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | No | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Not applicable (tested full dose) | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Yes | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.
Time frame: Day 1
Population: FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Excluded from Q2 | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | Yes | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | No | 6 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | No (FAIL per SAP) | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 6 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Yes | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | No | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | Yes | 6 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | No (FAIL per SAP) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | Did not participate | 0 participants |
Secondary
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 5 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Yes | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | No | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | Did not participate | 0 participants |
Secondary
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | Did not participate | 0 participants |
Secondary
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose.
Time frame: Day 1
Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Yes | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | No (FAIL per OAT) | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | Did not participate | 0 participants |
Secondary
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 1 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 5 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 1 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 5 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not useful at all | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Very useful | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Not very useful | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Somewhat useful | 0 participants |
Secondary
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 2 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 4 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 6 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 1 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 5 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not clear at all | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Very clear | 5 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Not very clear | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Somewhat clear | 1 participants |
Secondary
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 5 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 3 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 4 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 2 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 1 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 5 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 2 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 4 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 1 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 5 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Pushing plunger | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Setting the dose | 1 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Getting the air out of syringe | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Mixing the solution | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Attaching needle | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | No steps really difficult | 5 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | Other | 0 participants |
Secondary
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 4 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 1 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 1 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 3 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 3 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 1 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 5 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 6 participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 6 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 5 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 1 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 6 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 0 participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very easy | 6 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Very difficult | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Missing answer | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat difficult | 0 participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Somewhat easy | 0 participants |
Secondary
Time Required to Perform Segments 1 to 5
Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 148.8 seconds | Standard Deviation 37.2 |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 30.4 seconds | Standard Deviation 17.04 |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 34.4 seconds | Standard Deviation 29.55 |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 49.2 seconds | Standard Deviation 15.69 |
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 47.2 seconds | Standard Deviation 21.53 |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 73.0 seconds | Standard Deviation 63.11 |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 37.4 seconds | Standard Deviation 59.77 |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 38.8 seconds | Standard Deviation 53.64 |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 60.2 seconds | Standard Deviation 40.41 |
| Caverject 10 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 189.3 seconds | Standard Deviation 140.13 |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 42.3 seconds | Standard Deviation 14.19 |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 30.3 seconds | Standard Deviation 17.77 |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 176.0 seconds | Standard Deviation 72.92 |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 29.0 seconds | Standard Deviation 23.08 |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 71.8 seconds | Standard Deviation 22.69 |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 79.5 seconds | Standard Deviation 89.17 |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 19.2 seconds | Standard Deviation 11.96 |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 194.3 seconds | Standard Deviation 107.53 |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 53.8 seconds | Standard Deviation 30.73 |
| Caverject 10 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 30.0 seconds | Standard Deviation 26.71 |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 55.8 seconds | Standard Deviation 32.03 |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 246.5 seconds | Standard Deviation 131.85 |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 53.8 seconds | Standard Deviation 21.68 |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 20.0 seconds | Standard Deviation 13.07 |
| Caverject 20 mcg Device - 5 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 30.8 seconds | Standard Deviation 15.25 |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 42.6 seconds | Standard Deviation 5.86 |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 8.4 seconds | Standard Deviation 6.31 |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 50.2 seconds | Standard Deviation 35.9 |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 168.2 seconds | Standard Deviation 82.76 |
| Caverject 20 mcg Device - 10 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 17.4 seconds | Standard Deviation 13.24 |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 43.2 seconds | Standard Deviation 22.13 |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 142.3 seconds | Standard Deviation 105.78 |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 64.2 seconds | Standard Deviation 50.03 |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 27.3 seconds | Standard Deviation 20.38 |
| Caverject 20 mcg Device - 15 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 31.7 seconds | Standard Deviation 24.2 |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 30.8 seconds | Standard Deviation 17.51 |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) | 35.7 seconds | Standard Deviation 16.5 |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6) | 144.5 seconds | Standard Deviation 23.35 |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 63.3 seconds | Standard Deviation 24.82 |
| Caverject 20 mcg Device - 20 mcg Dose Setting | Time Required to Perform Segments 1 to 5 | Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) | 39.5 seconds | Standard Deviation 13.92 |
Post Hoc
DSSR Based on the Primary Objective
This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a failure only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step.
Time frame: Day 1
Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caverject 10 mcg Device - 2.5 mcg Dose Setting | DSSR Based on the Primary Objective | 83.33 percentage of participants |
| Caverject 10 mcg Device - 5 mcg Dose Setting | DSSR Based on the Primary Objective | 83.33 percentage of participants |
| Caverject 10 mcg Device - 7.5 mcg Dose Setting | DSSR Based on the Primary Objective | 100.00 percentage of participants |
| Caverject 10 mcg Device - 10 mcg Dose Setting | DSSR Based on the Primary Objective | 100.00 percentage of participants |
| Caverject 20 mcg Device - 5 mcg Dose Setting | DSSR Based on the Primary Objective | 100.00 percentage of participants |
| Caverject 20 mcg Device - 10 mcg Dose Setting | DSSR Based on the Primary Objective | 83.33 percentage of participants |
| Caverject 20 mcg Device - 15 mcg Dose Setting | DSSR Based on the Primary Objective | 100.00 percentage of participants |
| Caverject 20 mcg Device - 20 mcg Dose Setting | DSSR Based on the Primary Objective | 100.00 percentage of participants |
| All Participants | DSSR Based on the Primary Objective | 93.75 percentage of participants |