TriangleNCT01647711 · OUTCOME
Objective Response Rate for Patients With EGFR T790M Mutations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first drug administration until last drug administration, up to 420 days
What was measured
Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.
Analysis population: Treated set including participants with EGFR T790M positive mutations
Groups in this outcome
Afatinib 90mg
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 150mg
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 160mg
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 200mg
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
| Group | Source count |
|---|---|
| Afatinib 90mg | 1 |
| Afatinib 120mg | 0 |
| Afatinib 150mg | 7 |
| Afatinib 160mg | 1 |
| Afatinib 200mg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 90mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 150mg | 14.3 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 160mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Afatinib 200mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG002
- value
- 14.3
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- units
- Participants
- description
- Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.
- groups
- description
- Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG000
- title
- Afatinib 90mg
- description
- Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG001
- title
- Afatinib 120mg
- description
- Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG002
- title
- Afatinib 150mg
- description
- Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG003
- title
- Afatinib 160mg
- description
- Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
- id
- OG004
- title
- Afatinib 200mg
- param Type
- NUMBER
- population Description
- Treated set including participants with EGFR T790M positive mutations
- reporting Status
- POSTED
- time Frame
- From first drug administration until last drug administration, up to 420 days
- title
- Objective Response Rate for Patients With EGFR T790M Mutations
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice