TriangleNCT02435433 · OUTCOME
Time to Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
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
- From Randomization through First Date of Deterioration Observation (ECOG PS≥2) (Up to 28 Months)
What was measured
Time to deterioration in ECOG PS is defined as the time from the date of randomization to the first date observing ECOG PS 2 (ie, deterioration from baseline status of 0 \[fully active\] or 1 \[restricted in physically strenuous activity but ambulatory and able to carry out light work\]). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. Assessments included ECOG Performance Status (PS): 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled, cannot carry on any self-care. Totally confined to bed or chair, 5- Dead.
Analysis population: All randomized participants and had evaluable ECOG data. Censored participants without any post baseline assessments at randomization date were in the Ramucirumab + BSC arm = 141 and the Placebo + BSC arm =75. All randomized participants (including the censored participants) were included in the analyses.
Groups in this outcome
Ramucirumab + BSC
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
Placebo + BSC
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
| Group | Source count |
|---|---|
| Ramucirumab + BSC | 197 |
| Placebo + BSC | 95 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | NA | Not reported | 9.33 | NA | The median and upper limit 95% confidence interval upper limit had insufficient events to perform a meaningful statistical evaluation. |
| Placebo + BSC | NA | Not reported | 5.26 | NA | The median and upper limit 95% confidence interval had insufficient events to perform a meaningful statistical evaluation. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and upper limit 95% confidence interval upper limit had insufficient events to perform a meaningful statistical evaluation.
- group Id
- OG000
- lower Limit
- 9.33
- upper Limit
- NA
- value
- NA
- comment
- The median and upper limit 95% confidence interval had insufficient events to perform a meaningful statistical evaluation.
- group Id
- OG001
- lower Limit
- 5.26
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- Time to deterioration in ECOG PS is defined as the time from the date of randomization to the first date observing ECOG PS 2 (ie, deterioration from baseline status of 0 \[fully active\] or 1 \[restricted in physically strenuous activity but ambulatory and able to carry out light work\]). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. Assessments included ECOG Performance Status (PS): 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled, cannot carry on any self-care. Totally confined to bed or chair, 5- Dead.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
- id
- OG000
- title
- Ramucirumab + BSC
- description
- Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEDIAN
- population Description
- All randomized participants and had evaluable ECOG data. Censored participants without any post baseline assessments at randomization date were in the Ramucirumab + BSC arm = 141 and the Placebo + BSC arm =75. All randomized participants (including the censored participants) were included in the analyses.
- reporting Status
- POSTED
- time Frame
- From Randomization through First Date of Deterioration Observation (ECOG PS≥2) (Up to 28 Months)
- title
- Time to Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice