TriangleNCT04504825 · OUTCOME
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS)
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, Week 50
What was measured
The KCCQ-OS is a 23-item self-administered questionnaire that quantifies physical function, symptoms, social function, self-efficacy and knowledge and quality of life. It uses an ordinal, adjectival (Likert) scale. Participants provide their level of agreement or disagreement with an agree-disagree scale for a series of statements. The questionnaire captures how the participants feel physically. The overall score was calculated as the sum from all 23 items and ranges from 0 to 100, where higher scores reflected better health status (fewer symptoms, fewer social or physical limitations, and better quality of life).
Analysis population: Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.
Groups in this outcome
CAEL-101 + Plasma Cell Dyscrasia Treatment
During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
Placebo + Plasma Cell Dyscrasia Treatment
During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 32 |
| Placebo + Plasma Cell Dyscrasia Treatment | 17 |
Reported measurements
Overall (All Randomized Participants)
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 32 |
| Placebo + Plasma Cell Dyscrasia Treatment | 17 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 21.12 | 27.641 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 10.51 | 28.007 | Not reported | Not reported | Not reported |
FLC Subtype Kappa
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 11 |
| Placebo + Plasma Cell Dyscrasia Treatment | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 20.07 | 27.863 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 3.65 | Not reported | Not reported | Not reported | Not reported |
FLC Subtype Lambda
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 20 |
| Placebo + Plasma Cell Dyscrasia Treatment | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 22.31 | 28.773 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 10.94 | 28.868 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 27.641
- value
- 21.12
- group Id
- OG001
- spread
- 28.007
- value
- 10.51
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Overall (All Randomized Participants)
- categories
- measurements
- group Id
- OG000
- spread
- 27.863
- value
- 20.07
- group Id
- OG001
- value
- 3.65
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- FLC Subtype Kappa
- categories
- measurements
- group Id
- OG000
- spread
- 28.773
- value
- 22.31
- group Id
- OG001
- spread
- 28.868
- value
- 10.94
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- FLC Subtype Lambda
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- The KCCQ-OS is a 23-item self-administered questionnaire that quantifies physical function, symptoms, social function, self-efficacy and knowledge and quality of life. It uses an ordinal, adjectival (Likert) scale. Participants provide their level of agreement or disagreement with an agree-disagree scale for a series of statements. The questionnaire captures how the participants feel physically. The overall score was calculated as the sum from all 23 items and ranges from 0 to 100, where higher scores reflected better health status (fewer symptoms, fewer social or physical limitations, and better quality of life).
- dispersion Type
- Standard Deviation
- groups
- description
- During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
- id
- OG000
- title
- CAEL-101 + Plasma Cell Dyscrasia Treatment
- description
- During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
- id
- OG001
- title
- Placebo + Plasma Cell Dyscrasia Treatment
- param Type
- MEAN
- population Description
- Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 50
- title
- Change From Baseline in the Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice