TriangleNCT04512235 · OUTCOME
All-cause Mortality
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, analysis for the study was conducted 18-49 months after the study randomization.)
What was measured
All-cause mortality was defined as death on or before the end of the PETP. Otherwise, participants who were alive at the end of the PETP (last participant randomized plus 18 months) were censored at their last known alive date recorded within the PETP. All deaths, regardless of causality or whether they were reported as a reason for study discontinuation, are reported in the All-Cause Mortality section.
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'.
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 | 187 |
| Placebo + Plasma Cell Dyscrasia Treatment | 94 |
Reported measurements
Overall (All Randomized Participants)
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 187 |
| Placebo + Plasma Cell Dyscrasia Treatment | 94 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 44 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 30 | Not reported | Not reported | Not reported | Not reported |
FLC Subtype Kappa
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 23 |
| Placebo + Plasma Cell Dyscrasia Treatment | 18 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 3 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 9 | Not reported | Not reported | Not reported | Not reported |
FLC Subtype Lambda
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 162 |
| Placebo + Plasma Cell Dyscrasia Treatment | 75 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 41 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 21 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 94
- units
- Participants
- title
- Overall (All Randomized Participants)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- FLC Subtype Kappa
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 21
- denoms
- counts
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 75
- units
- Participants
- title
- FLC Subtype Lambda
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 94
- units
- Participants
- description
- All-cause mortality was defined as death on or before the end of the PETP. Otherwise, participants who were alive at the end of the PETP (last participant randomized plus 18 months) were censored at their last known alive date recorded within the PETP. All deaths, regardless of causality or whether they were reported as a reason for study discontinuation, are reported in the All-Cause Mortality section.
- 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
- COUNT_OF_PARTICIPANTS
- 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'.
- reporting Status
- POSTED
- time Frame
- Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, analysis for the study was conducted 18-49 months after the study randomization.)
- title
- All-cause Mortality
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice