TriangleNCT02411448 · OUTCOME
Part B: Duration of Response (DoR)
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
- Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months)
What was measured
DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Analysis population: Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy.
Groups in this outcome
Part B: Ramucirumab+ Erlotinib
Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Placebo+ Erlotinib
Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
| Group | Source count |
|---|---|
| Part B: Ramucirumab+ Erlotinib | 171 |
| Part B: Placebo+ Erlotinib | 168 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Ramucirumab+ Erlotinib | 18.0 | Not reported | 13.9 | 19.8 | Not reported |
| Part B: Placebo+ Erlotinib | 11.1 | Not reported | 9.7 | 12.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.477
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.805
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.619
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.477
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.805
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.619
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.9
- upper Limit
- 19.8
- value
- 18.0
- group Id
- OG001
- lower Limit
- 9.7
- upper Limit
- 12.3
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 168
- units
- Participants
- description
- DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG000
- title
- Part B: Ramucirumab+ Erlotinib
- description
- Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG001
- title
- Part B: Placebo+ Erlotinib
- param Type
- MEDIAN
- population Description
- Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy.
- reporting Status
- POSTED
- time Frame
- Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months)
- title
- Part B: Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice