TriangleNCT04512235 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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, the primary analysis for the study was conducted 18-49 months after the study randomization.)
What was measured
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, at any dose, that was not necessarily related to the treatment. A TEAE was an AE with an occurrence defined as follows: last study intervention day-first study intervention day + 140 days. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Analysis population: Safety Set: all randomized participants who received at least 1 dose of the study intervention. As prespecified, data collected and reported as 'Overall (All Safety Set 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 Safety Set 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 | 187 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 94 | 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 | 23 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 18 | 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 | 162 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 75 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 94
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 94
- units
- Participants
- title
- Overall (All Safety Set Participants)
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 18
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- FLC Subtype Kappa
- categories
- measurements
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 75
- 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
- An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, at any dose, that was not necessarily related to the treatment. A TEAE was an AE with an occurrence defined as follows: last study intervention day-first study intervention day + 140 days. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' 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
- Safety Set: all randomized participants who received at least 1 dose of the study intervention. As prespecified, data collected and reported as 'Overall (All Safety Set 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, the primary analysis for the study was conducted 18-49 months after the study randomization.)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice