TriangleNCT01484275 · OUTCOME
Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores
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
Time to worsening in the BPI worst item is defined as the time between randomization and the first documentation of a worsening in the BPI worst item. It has 2 domains reflecting pain severity and pain interference with domains of functioning and well-being. The selected item refers to the "worst" pain the patient has experienced over the past 24 hours. This item has been found to be most responsive to interference with key domains of functioning and well-being and may be used as a single item. Responses are provided on an 11-point numeric rating scale ranging from 0 "no pain" to 10 "pain as bad as you can imagine". Responses are described as mild (1 to 4), moderate (5 to 6) and severe (7 to 10). Worsening in the BPI worst item is defined as 2 points increase from baseline.
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 | 652.0 | Not reported | 226 | NA | Here, NA signifies that upper limit of CI was not estimable due to an insufficient number of events. |
| Placebo | 453.0 | Not reported | 277 | NA | Here, NA signifies that upper limit of CI was not estimable due to an insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, NA signifies that upper limit of CI was not estimable due to an insufficient number of events.
- group Id
- OG000
- lower Limit
- 226
- upper Limit
- NA
- value
- 652.0
- comment
- Here, NA signifies that upper limit of CI was not estimable due to an insufficient number of events.
- group Id
- OG001
- lower Limit
- 277
- upper Limit
- NA
- value
- 453.0
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Time to worsening in the BPI worst item is defined as the time between randomization and the first documentation of a worsening in the BPI worst item. It has 2 domains reflecting pain severity and pain interference with domains of functioning and well-being. The selected item refers to the "worst" pain the patient has experienced over the past 24 hours. This item has been found to be most responsive to interference with key domains of functioning and well-being and may be used as a single item. Responses are provided on an 11-point numeric rating scale ranging from 0 "no pain" to 10 "pain as bad as you can imagine". Responses are described as mild (1 to 4), moderate (5 to 6) and severe (7 to 10). Worsening in the BPI worst item is defined as 2 points increase from baseline.
- 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
- Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice