NCT06099782 · OUTCOME
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
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
- Up to approximately Day 106
What was measured
The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, and time. The TASQ IV does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-IV Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Analysis population: The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, and subsequently answered question 1 of the TASQ IV.
Groups in this outcome
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
| Group | Source count |
|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV | 57 |
| Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC | 61 |
Reported measurements
Very satisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV | 45.6 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC | 62.3 | Not reported | Not reported | Not reported | Not reported |
Satisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC | 29.5 | Not reported | Not reported | Not reported | Not reported |
Neither satisfied nor dissatisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV | 17.5 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC | 4.9 | Not reported | Not reported | Not reported | Not reported |
Dissatisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV | 1.8 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC | 1.6 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV | 1.8 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC | 1.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 45.6
- group Id
- OG001
- value
- 62.3
- title
- Very satisfied
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 29.5
- title
- Satisfied
- categories
- measurements
- group Id
- OG000
- value
- 17.5
- group Id
- OG001
- value
- 4.9
- title
- Neither satisfied nor dissatisfied
- categories
- measurements
- group Id
- OG000
- value
- 1.8
- group Id
- OG001
- value
- 1.6
- title
- Dissatisfied
- categories
- measurements
- group Id
- OG000
- value
- 1.8
- group Id
- OG001
- value
- 1.6
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, and time. The TASQ IV does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-IV Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
- groups
- description
- In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.
- id
- OG000
- title
- Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
- description
- In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
- id
- OG001
- title
- Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
- param Type
- NUMBER
- population Description
- The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, and subsequently answered question 1 of the TASQ IV.
- reporting Status
- POSTED
- time Frame
- Up to approximately Day 106
- title
- Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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