TriangleNCT02181413 · OUTCOME
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline up to EOT (up to Month 24)
What was measured
ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower scores indicate improvement.
Analysis population: Safety population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Groups in this outcome
Placebo
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
Ixazomib Citrate
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
| Group | Source count |
|---|---|
| Placebo | 252 |
| Ixazomib Citrate | 371 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0.1 | 0.63 | Not reported | Not reported | Not reported |
| Ixazomib Citrate | 0.0 | 0.54 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.63
- value
- 0.1
- group Id
- OG001
- spread
- 0.54
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 252
- group Id
- OG001
- value
- 371
- units
- Participants
- description
- ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower scores indicate improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
- id
- OG000
- title
- Placebo
- description
- Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
- id
- OG001
- title
- Ixazomib Citrate
- param Type
- MEAN
- population Description
- Safety population was defined as participants who received at least 1 dose of ixazomib citrate or placebo. Overall number of participants analyzed indicates the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Baseline up to EOT (up to Month 24)
- title
- Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice