TriangleNCT02485691 · OUTCOME
Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score
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
- Baseline until pain progression, first further anticancer therapy, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
What was measured
Pain response as per BPI-SF was defined as a decrease of at least 30% from Baseline in the average of BPI-SF pain intensity score observed at 2 consecutive evaluations \>=3 weeks apart without increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Percentage of Participants Achieving Pain Response assessed using BPI-SF Pain Intensity Score were reported.
Analysis population: Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with baseline assessment and at least one post-baseline assessment before any further anti-cancer therapy for specified outcome measure.
Groups in this outcome
Cabazitaxel
Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
Abiraterone Acetate or Enzalutamide
Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
| Group | Source count |
|---|---|
| Cabazitaxel | 111 |
| Abiraterone Acetate or Enzalutamide | 109 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel | 45.9 | Not reported | 36.7 | 55.2 | Not reported |
| Abiraterone Acetate or Enzalutamide | 19.3 | Not reported | 11.9 | 26.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.7
- upper Limit
- 55.2
- value
- 45.9
- group Id
- OG001
- lower Limit
- 11.9
- upper Limit
- 26.7
- value
- 19.3
- denoms
- counts
- group Id
- OG000
- value
- 111
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- Pain response as per BPI-SF was defined as a decrease of at least 30% from Baseline in the average of BPI-SF pain intensity score observed at 2 consecutive evaluations \>=3 weeks apart without increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Percentage of Participants Achieving Pain Response assessed using BPI-SF Pain Intensity Score were reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
- id
- OG000
- title
- Cabazitaxel
- description
- Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide
- param Type
- NUMBER
- population Description
- Analysis was performed on subset of ITT population (any participant who had been allocated to a randomized treatment, analyzed according to group allocated) with baseline assessment and at least one post-baseline assessment before any further anti-cancer therapy for specified outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline until pain progression, first further anticancer therapy, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
- title
- Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice