TriangleNCT01802632 · OUTCOME
Duration of Response (DoR) for Dose Expansion Population
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 approximately 21 months (at time of 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 was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
Analysis population: All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
Groups in this outcome
Dose Expansion
Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
| Group | Source count |
|---|---|
| Dose Expansion | 108 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion | 11.1 | Not reported | 8.3 | 13.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 13.8
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 108
- 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 was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
- id
- OG000
- title
- Dose Expansion
- param Type
- MEDIAN
- population Description
- All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
- reporting Status
- POSTED
- time Frame
- RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
- title
- Duration of Response (DoR) for Dose Expansion Population
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice