TriangleNCT05010629 · OUTCOME
Mean Score of Global Question 3 in UW-QOL
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.
What was measured
UW-QOL Global Question 3 assessed patients' overall QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding.
Analysis population: Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.
Groups in this outcome
9-ING-41 + Carboplatin (Part I)
Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
| Group | Source count |
|---|---|
| 9-ING-41 + Carboplatin (Part I) | 16 |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 16 |
Reported measurements
At baseline
| Group | Source count |
|---|---|
| 9-ING-41 + Carboplatin (Part I) | 16 |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9-ING-41 + Carboplatin (Part I) | 55 | 29.7 | Not reported | Not reported | Not reported |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 61.3 | 19.7 | Not reported | Not reported | Not reported |
At off-treatment
| Group | Source count |
|---|---|
| 9-ING-41 + Carboplatin (Part I) | 6 |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9-ING-41 + Carboplatin (Part I) | 53.3 | 30.1 | Not reported | Not reported | Not reported |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 57.5 | 24.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 29.7
- value
- 55
- group Id
- OG001
- spread
- 19.7
- value
- 61.3
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- At baseline
- categories
- measurements
- group Id
- OG000
- spread
- 30.1
- value
- 53.3
- group Id
- OG001
- spread
- 24.9
- value
- 57.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- At off-treatment
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- UW-QOL Global Question 3 assessed patients' overall QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- OG000
- title
- 9-ING-41 + Carboplatin (Part I)
- description
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- OG001
- title
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- param Type
- MEAN
- population Description
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.
- reporting Status
- POSTED
- time Frame
- Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.
- title
- Mean Score of Global Question 3 in UW-QOL
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice