NCT05511428 · OUTCOME
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- scores on a scale (0-100)
- Interval / dispersion
- Standard Deviation
- Time frame
- At Visit 3, Day 57
What was measured
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
Analysis population: Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 18 participants who provided complete and analyzable responses were included in the analysis for this outcome.
Groups in this outcome
Treatment (daratumumab and hyaluronidase-fihj)
Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
| Group | Source count |
|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (daratumumab and hyaluronidase-fihj) | 64.4 | 15.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.9
- value
- 64.4
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
- id
- OG000
- title
- Treatment (daratumumab and hyaluronidase-fihj)
- param Type
- MEAN
- population Description
- Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 18 participants who provided complete and analyzable responses were included in the analysis for this outcome.
- reporting Status
- POSTED
- time Frame
- At Visit 3, Day 57
- title
- Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3
- type
- SECONDARY
- unit Of Measure
- scores on a scale (0-100)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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