TriangleNCT02151981 · OUTCOME
Duration of Response (DoR) by Investigator Assessment
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
- RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
What was measured
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Analysis population: Full Analysis Set (All randomised patients)
Groups in this outcome
Osimertinib 80mg
Daily single dose of Osimertinib 80mg
Chemotherapy
Platinum-based doublet chemotherapy
| Group | Source count |
|---|---|
| Osimertinib 80mg | 279 |
| Chemotherapy | 140 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib 80mg | 9.7 | Not reported | 8.3 | 11.6 | Not reported |
| Chemotherapy | 4.1 | Not reported | 3.0 | 5.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 9.57
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- param Type
- Ratio of Expected (DoR)
- param Value
- 6.22
- statistical Comment
- Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients
- statistical Method
- formulae provided in Ellis S et al 2008
Complete source fields
- analyses
- ci Lower Limit
- 4.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 9.57
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.001
- param Type
- Ratio of Expected (DoR)
- param Value
- 6.22
- statistical Comment
- Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients
- statistical Method
- formulae provided in Ellis S et al 2008
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 11.6
- value
- 9.7
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 5.6
- value
- 4.1
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 140
- units
- Participants
- description
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Daily single dose of Osimertinib 80mg
- id
- OG000
- title
- Osimertinib 80mg
- description
- Platinum-based doublet chemotherapy
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- Full Analysis Set (All randomised patients)
- reporting Status
- POSTED
- time Frame
- RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
- title
- Duration of Response (DoR) by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice