TriangleNCT01001442 · OUTCOME
Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Starting with first study drug administration until death or 3 years from first study treatment.
What was measured
Progressive disease Requires any one or more of the following: Increase of ≥ 25% from baseline in * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL) (increases of ≥ 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL). * Urine M-component and/or (the absolute increase must be ≥ 200mg/24h). Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL. Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%). Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.
Analysis population: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34).
Groups in this outcome
BT062
BT062: intravenous administration
| Group | Source count |
|---|---|
| BT062 | 34 |
Reported measurements
TTP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 | 3 | Not reported | 1.1 | 4.4 | Not reported |
PFS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 | 3 | Not reported | 1.1 | 3.9 | Not reported |
OS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 | 26.7 | Not reported | 13.2 | 42.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 4.4
- value
- 3
- title
- TTP
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 3.9
- value
- 3
- title
- PFS
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.2
- upper Limit
- 42.4
- value
- 26.7
- title
- OS
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Progressive disease Requires any one or more of the following: Increase of ≥ 25% from baseline in * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL) (increases of ≥ 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL). * Urine M-component and/or (the absolute increase must be ≥ 200mg/24h). Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL. Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%). Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- BT062: intravenous administration
- id
- OG000
- title
- BT062
- param Type
- MEDIAN
- population Description
- The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34).
- reporting Status
- POSTED
- time Frame
- Starting with first study drug administration until death or 3 years from first study treatment.
- title
- Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice