TriangleNCT01802632 · OUTCOME
Progression-Free Survival (PFS) 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: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 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 | 175 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion | 9.7 | Not reported | 8.3 | 12.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 12.5
- value
- 9.7
- denoms
- counts
- group Id
- OG000
- value
- 175
- units
- Participants
- description
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 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
- Progression-Free Survival (PFS) for Dose Expansion Population
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice