TriangleNCT03361748 · OUTCOME
Percentage of Participants Who Achieved >= VGPR and MRD Negative Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From screening to the end of follow up (Approximately 5 years and 2 months)
What was measured
Percentage of participants who achieved ≥ VGPR and MRD negative status at a sensitivity of 10-⁵ at any time point within 3 months prior to achieving at least VGPR until the time of PD/death. MRD in the bone marrow will be measured using both next generation sequencing (NGS) techniques measuring immunoglobulin gene rearrangements of the malignant clone. MRD will be reported with a sensitivity of 10-⁴, 10-⁵, and 10-⁶ nucleated cells. The primary analysis for MRD negative response will use the sensitivity of 10-⁵. MRD = Minimal Residual Disease PD = Progressive Disease VGPR = Very good partial response.
Analysis population: All Treated Population
Groups in this outcome
BB2121
BB2121
| Group | Source count |
|---|---|
| BB2121 | 137 |
Reported measurements
10^(-4) Sensitivity
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BB2121 | 41.6 | Not reported | 33.3 | 50.3 | Not reported |
10^(-5) Sensitivity
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BB2121 | 40.9 | Not reported | 32.6 | 49.6 | Not reported |
10^(-6) Sensitivity
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BB2121 | 24.8 | Not reported | 17.8 | 32.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.3
- upper Limit
- 50.3
- value
- 41.6
- title
- 10^(-4) Sensitivity
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.6
- upper Limit
- 49.6
- value
- 40.9
- title
- 10^(-5) Sensitivity
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.8
- upper Limit
- 32.9
- value
- 24.8
- title
- 10^(-6) Sensitivity
- denoms
- counts
- group Id
- OG000
- value
- 137
- units
- Participants
- description
- Percentage of participants who achieved ≥ VGPR and MRD negative status at a sensitivity of 10-⁵ at any time point within 3 months prior to achieving at least VGPR until the time of PD/death. MRD in the bone marrow will be measured using both next generation sequencing (NGS) techniques measuring immunoglobulin gene rearrangements of the malignant clone. MRD will be reported with a sensitivity of 10-⁴, 10-⁵, and 10-⁶ nucleated cells. The primary analysis for MRD negative response will use the sensitivity of 10-⁵. MRD = Minimal Residual Disease PD = Progressive Disease VGPR = Very good partial response.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- BB2121
- id
- OG000
- title
- BB2121
- param Type
- NUMBER
- population Description
- All Treated Population
- reporting Status
- POSTED
- time Frame
- From screening to the end of follow up (Approximately 5 years and 2 months)
- title
- Percentage of Participants Who Achieved >= VGPR and MRD Negative Status
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice