TriangleNCT01484275 · OUTCOME
Progression-Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 4.7 Years
What was measured
PFS is defined as the time between randomization and initial documented PD according to the CRAB - International Myeloma Working Group (IMWG) criteria or date of death, whichever occurs first. PD is defined as presence of an M-component in serum plus clonal plasma cells in the bone marrow plus 1 or more of the following: Calcium elevation (\> 11.5 mg/dL \[\> 2.88 mmol/L\]); Renal insufficiency (creatinine \> 2 mg/dL \[177 \[micro mol/L or more\]); Anemia (\<10 g/dL or 2 g/dL) lower than LLN) \[hemoglobin \< 6.5 mmol/L or 1.25 mmol/L lower than LLN\]); Bone disease (lytic lesions or osteopenia).
Analysis population: ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
Groups in this outcome
Siltuximab
Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
Placebo
Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
| Group | Source count |
|---|---|
| Siltuximab | 43 |
| Placebo | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab | NA | Not reported | 703 | NA | Here, NA signifies that median and upper limit of confidence interval (CI) was not estimable due to less number of events. |
| Placebo | 715.0 | Not reported | 490 | 1232 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, NA signifies that median and upper limit of confidence interval (CI) was not estimable due to less number of events.
- group Id
- OG000
- lower Limit
- 703
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 490
- upper Limit
- 1232
- value
- 715.0
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- PFS is defined as the time between randomization and initial documented PD according to the CRAB - International Myeloma Working Group (IMWG) criteria or date of death, whichever occurs first. PD is defined as presence of an M-component in serum plus clonal plasma cells in the bone marrow plus 1 or more of the following: Calcium elevation (\> 11.5 mg/dL \[\> 2.88 mmol/L\]); Renal insufficiency (creatinine \> 2 mg/dL \[177 \[micro mol/L or more\]); Anemia (\<10 g/dL or 2 g/dL) lower than LLN) \[hemoglobin \< 6.5 mmol/L or 1.25 mmol/L lower than LLN\]); Bone disease (lytic lesions or osteopenia).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
- id
- OG000
- title
- Siltuximab
- description
- Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
- reporting Status
- POSTED
- time Frame
- Up to 4.7 Years
- title
- Progression-Free Survival
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice