TriangleNCT01401166 · OUTCOME
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)
What was measured
Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from "Strongly Disagree" to "Strongly Agree". The percentage of participants with a positive response (either "Agree" or "Strongly Agree") to each questionnaire statement was reported.
Analysis population: Safety Population. The "Number of Participants Analyzed" reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin.
Groups in this outcome
Cohort 1: SC (SID) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
Cohort 1: IV Then SC (SID) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
| Group | Source count |
|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 19 |
| Cohort 1: IV Then SC (SID) Herceptin | 15 |
Reported measurements
Comfortable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 94.7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 86.7 | Not reported | Not reported | Not reported | Not reported |
Convenient
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 100 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 100 | Not reported | Not reported | Not reported | Not reported |
Confident
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 100 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 100 | Not reported | Not reported | Not reported | Not reported |
Satisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 100 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 93.3 | Not reported | Not reported | Not reported | Not reported |
Would Use Again
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 100 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 93.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 94.7
- group Id
- OG001
- value
- 86.7
- title
- Comfortable
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 100
- title
- Convenient
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 100
- title
- Confident
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 93.3
- title
- Satisfied
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 93.3
- title
- Would Use Again
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from "Strongly Disagree" to "Strongly Agree". The percentage of participants with a positive response (either "Agree" or "Strongly Agree") to each questionnaire statement was reported.
- groups
- description
- Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
- id
- OG000
- title
- Cohort 1: SC (SID) Then IV Herceptin
- description
- Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
- id
- OG001
- title
- Cohort 1: IV Then SC (SID) Herceptin
- param Type
- NUMBER
- population Description
- Safety Population. The "Number of Participants Analyzed" reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin.
- reporting Status
- POSTED
- time Frame
- Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)
- title
- Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice